INDIANAPOLIS, Sept. 24, 2026 /PRNewswire/ -- Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) approval of Onswik™ (insulin efsitora alfa-gobe), a once-weekly basal insulin, indicated along with diet and...

FORT LEE, N.J., September 23, 2026 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for cancer patients...

AUSTIN, Texas--(BUSINESS WIRE) September 18, 2026 --IntraBio Inc., a leader in the discovery, development, and commercialization of novel therapies for rare and common neurodegenerative diseases, today announced that the U.S. Food and Drug...

INDIANAPOLIS, Sept. 18, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to Inluriyo (imlunestrant), an oral estrogen receptor (ER)...

NEW YORK, Sept. 16, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has approved...

NOVATO, Calif., Sept. 17, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the U.S. Food and Drug Administration (FDA) granted standard full approval of Fayuvi (rebisufligene etisparvovec-hopf), also known...

September 17, 2026 -- Bayer today announced that the U.S. Food and Drug Administration (FDA) approved Kerendia® (finerenone) to reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained estimated...

GAITHERSBURG, Md., Aug. 28, 2026 /PRNewswire/ -- Novavax, Inc.'s (Nasdaq: NVAX) partners have received approvals for the Nuvaxovid™ formulation to target the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season in major markets...

Boston, MA – 14 September, 2026 – Curium™ announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Bexlutry™ lutetium Lu 177 dotatate injection for the treatment of...

THOUSAND OAKS, Calif., Sept. 14, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved an update to the Imdelltra (tarlatamab-dlle) Prescribing Information that substantially reduces...

WOBURN, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today...

Melbourne (Australia) and Indianapolis, IN (United States) | September 14, 2026 -- Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Pixclara&reg...

SAN JOSE, CA AND TAIPEI, TW / September 11, 2026 / Handa Pharmaceuticals, Inc. (“Handa” or the “Company”) (TSE:6620) announced that the U.S. Food and Drug Administration (“FDA”) has granted final approval to...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--September 11, 2026-- Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its leading...

Leiden, the Netherlands, September 11, 2026: Pharming (Euronext Amsterdam: PHARM/Nasdaq: PHAR), a global biotechnology company focused on rare immune and genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has...

WHIPPANY, N.J., September 9, 2026 – Bayer announced today that following Priority Review and Breakthrough Therapy Designation, the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hyrnuo® (sevabertinib), for the...

Berlin, September 9, 2026 – Following Priority Review and Breakthrough Therapy Designation, the U.S. Food and Drug Administration (FDA) has granted accelerated approval for sevabertinib as a first-line treatment option for adult patients with...

September 4, 2026 -- AstraZeneca’s Etcamah (camizestrant) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (abemaciclib, palbociclib or ribociclib) has been approved in the US for the treatment of adult patients with...

September 03, 2026 -- The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients. Zanvastro is the first FDA-approved treatment for Alexander disease...

August 28, 2026 -- The U.S. Food and Drug Administration has approved Stelara (ustekinumab) injection for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients aged 2 years old and older. On April 15, 2026...

BURLINGTON, Mass.--(BUSINESS WIRE)--August 31, 2026 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446) today announced the U.S. Food and Drug Administration (FDA) has approved BESREMi® (ropeginterferon...

INDIANAPOLIS, August 28, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved Mounjaro (tirzepatide), a dual GIP and GLP-1 hormone receptor agonist, to lower the risk of...

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo™ (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet...

NEW YORK & MAINZ, Germany--(BUSINESS WIRE) August 27, 2026 -- Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the U.S. Food and Drug Administration (FDA) has approved...

CAMBRIDGE, MA / ACCESS Newswire / August 27, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2026-2027 formulas for...

August 28, 2026 -- The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells. The excess cells can...

London, 26 August 2026 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced that the U.S. Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir...

SAN CARLOS, Calif.--(BUSINESS WIRE) Aug 25, 2026 -- BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics...

BASEL, Switzerland and LONDON and NEW YORK, August 27, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced that the U.S. Food and Drug Administration (FDA) has approved Lisraya (brepocitinib) 30 mg for the treatment of adults with...

REDWOOD CITY, Calif., Aug. 26, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a global commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted...

DUBLIN , August 25, 2026 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration ( FDA ) approved two Ziihera (zanidatamab-hrii)-containing regimens for the first-line treatment of adults...

SPRING HOUSE, Pa. August 24, 2026 - Johnson & Johnson (NYSE: JNJ) today announced the U.S. Food and Drug Administration (FDA) approval of Imaavy® (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) – a...

NOVATO, Calif., August 19, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Genglycos™ (pariglasgene brecaparvovec-opnr)...

TARRYTOWN, N.Y., August 19, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted approval for Pasatru™ (garetosmab-grts) to reduce formation of new...

CINCINNATI--(BUSINESS WIRE)--LIB Therapeutics, Inc. (LIB), a privately held biopharmaceutical company with a singular focus on helping high-risk patients achieve their cholesterol goals, today announced the U.S. Food and Drug Administration (FDA)...

BEDFORD, Mass., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and...

PRINCETON, N.J.--(BUSINESS WIRE)--August 13, 2026 Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved ZENBEXUS™ (iberdomide) in combination with daratumumab and hyaluronidase-fihj...

NUTLEY, N.J., AUGUST 5, 2026 – Reckitt announced today a milestone for the cold and flu category and the company: Mucinex® 12HR Cold & Fever Multi-Symptom is the first U.S. Food and Drug Administration (FDA)-approved over-the-counter...

WOBURN, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration...

CAMBRIDGE, MA / ACCESS Newswire / August 5, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mFLUSIVA® (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults...

OSAKA, Japan and CAMBRIDGE, Massachusetts, August 5, 2026 – Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) approved Orzeyful™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the...

CHICAGO--- July 30, 2026 -- Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company headquartered in Chicago and focused on the development and commercialization of generic injectable medicines...

Basel, July 31, 2026 – Novartis today announced the US Food and Drug Administration (FDA) approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for patients with...

PITTSBURGH, July 29, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved Gwyn Lo™ (norelgestromin and ethinyl estradiol transdermal...

July 1 , 2026 Celltrion announced on the 1st that it has obtained Interchangeability from the U.S. Food and Drug Administration (FDA) for its blood cancer treatment, 'Truxima' ( active ingredient : rituximab). Truxima is the first rituximab...

WESTLAKE VILLAGE, Calif., and BOSTON, July 24, 2026 (Globe Newswire) – MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for...

PRINCETON, N.J. and TOKYO, JAPAN – July 24, 2026 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the U.S. Food and Drug Administration (FDA) has granted...

ISELIN, N.J., July 24, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/Lytenava (bevacizumab-vikg, bevacizumab gamma) for the treatment of...

SUMMIT, N.J., July 24, 2026 — Tylenol®, the #1 doctor‑recommended pain relief brand, today announced that the U.S. Food and Drug Administration (FDA) has approved Tylenol® with Naproxen—the first and only over‑the‑counter...

London, UK July 22, 2026 -- GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for the treatment of adult patients with locally advanced or metastatic...

Elmwood Park, New Jersey, July 21, 2026: Glenmark Specialty S.A. (Glenmark) today announced that U.S. FDA has approved the expanded use of Ryaltris (olopatadine hydrochloride and mometasone furoate) Nasal Spray, 665 mcg/25 mcg per spray, for the...

On July 14, 2026, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET...

Basel, July 17, 2026 – Novartis today announced that the US Food and Drug Administration (FDA) has granted traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN)...

RAHWAY, N.J.--(BUSINESS WIRE) July 16, 2026 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide) tablets 20 mg as an adjunct...

RALEIGH, N.C. – June 26, 2026 – Merz Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. Prescribing Information for Xeomin® (incobotulinumtoxinA), expanding the pediatric...

NEW YORK & TOKYO--(BUSINESS WIRE) July 10, 2026 -- Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has...

RAHWAY, N.J.--(BUSINESS WIRE) July 10, 2026 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) and Keytruda Qlex...

TOKYO and CAMBRIDGE, Mass., July 13, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a...

MINNEAPOLIS, July 14, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor indications, today announced that the U.S. Food and Drug...

Paris, July 10, 2026. The US Food and Drug Administration (FDA) has approved subcutaneous (SC) Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all...

JERSEY CITY, N.J.-- June 10, 2026 (BUSINESS WIRE)-- Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) approval of the supplemental Biologics License Application (sBLA) for Tofidence® (tocilizumab-bavi)...

BURLINGTON, Mass, June 26, 2026 – PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to...

PARAMUS, N.J., July 8, 2026 /PRNewswire/ -- On July 2, 2026, the U.S. Food and Drug Administration (FDA) approved the use of wilate® (von Willebrand Factor/Coagulation Factor VIII Complex [Human]) for routine prophylaxis to reduce the frequency...

BOSTON--(BUSINESS WIRE)--Jul. 1, 2026-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has approved expanded use of Casgevy (exagamglogene autotemcel) for the treatment of people...

LOUISVILLE, Ky., June 22, 2026 /PRNewswire/ -- USWM CT, LLC (US WorldMeds) announced that the U.S. Food and Drug Administration (FDA) has granted full approval of Tecelra (afamitresgene autoleucel) and expanded its indication to include pediatric...

BRISBANE, Calif., July 07, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Trutakna (atacicept-vymj) accelerated...

June 29, 2026. The Food and Drug Administration (FDA) approved an update to the Prescribing Information for Xeomin (incobotulinumtoxinA; Merz Therapeutics, Raleigh, NC), expanding its indication to include children and adolescents aged 2 years and...

MENLO PARK, CA, June 30, 2026 – Orca Bio, a commercial-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced the U.S. Food and Drug Administration (FDA) has approved...

MENLO PARK, CA, June 30, 2026 – Orca Bio, a commercial-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced the U.S. Food and Drug Administration (FDA) has approved...

FOSTER CITY, Calif.--(BUSINESS WIRE) -- June 24, 2026 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvy (sacituzumab govitecan-hziy), a first-in-class Trop-2-directed...

Mumbai, India, Naples, Fla., June 5, 2026 -- Global pharma major Lupin Limited (Lupin) today announced that the United States Food and Drug Administration (U.S. FDA) has approved its ranibizumab, Ranluspec (ranibizumab-hkdz), as an...

BEIJING, June 1, 2026 /PRNewswire/ -- Cipepofol (CYPSEDO) Injection (hereinafter "Cipepofol"), a Class 1 innovative intravenous anesthetic independently developed by Haisco Pharmaceutical Group, has officially received marketing approval from the...

CAMBRIDGE, UK – June 2, 2026 – Cycle Pharmaceuticals (Cycle) announces the FDA approval of Cavhanza (nilotinib) Orally Disintegrating Tablets. Launching soon, the Cavhanza formulation is specifically designed to improve solubility and...

WESTLAKE VILLAGE, Calif., June 29, 2026 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the...

June 12, 2026. RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) and Keytruda Qlex...

12 June 2026 -- AstraZeneca’s Truqap (capivasertib) in combination with abiraterone and prednisone has been approved in the US as the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway...

June 18, 2026, 6:45 am EDT. RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Capvaxive...

Wednesday, June 24, 2026 - 02:10pm: NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved Ibrance (palbociclib) in combination with trastuzumab, with or without pertuzumab, and...

June 25, 2026, 6:45 am EDT. RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) and Keytruda Qlex...

NORTH CHICAGO, Ill., June 26, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) for the treatment of children six years of age and older with...

WALTHAM, Mass.–(BUSINESS WIRE)– June 26, 2026 -- Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare...

Berlin, June 15, 2026 – Bayer today announced that the U.S. Food and Drug Administration (FDA) approved gadoquatrane, a new, intravenous macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) under the brand name Ambelvist™. The...

CARLSBAD, Calif.--(BUSINESS WIRE)--Jun. 24, 2026-- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has approved Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides (TG) and...

June 16, 2026 -- The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose...

GSK plc (LSE/NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) today announced that the US Food and Drug Administration (FDA) has approved Utebzi, an oral antibiotic for the treatment of complicated urinary tract infections (cUTIs) including...

Paris, June 13, 2026. The US Food and Drug Administration (FDA) has granted accelerated approval to Tzield (teplizumab-mzwv) to delay the decline in endogenous (own) insulin production in children aged eight to 17 years recently diagnosed with...

INDIANAPOLIS, June 9, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved a regimen of one maintenance dose every eight weeks of a single injection (250 mg/2 mL) of Ebglyss...

NEW YORK--(BUSINESS WIRE) June 08, 2026 -- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Hympavzi (marstacimab-hncq) to include the treatment of patients with...

HORSHAM, PA – (May 28, 2026) – Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to include evidence in the Tremfya...

OSAKA, Japan, June 1, 2026 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has approved...

MUMBAI & SHORT HILLS, NEW JERSEY May 30, 2026 – Wockhardt today announced that the U.S. Food and Drug Administration (FDA) has approved Zaynich (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adults with...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 29, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for...

May 28, 2026 -- AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy has been approved in the US for the treatment of adult patients with BCG-naïve, high-risk...

NORTH CHICAGO, Ill., May 27, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Decnupaz (pivekimab sunirine-pvzy) for the treatment of adult patients with BPDCN, an ultra-rare and...

BOSTON--(BUSINESS WIRE) May 27, 2026 -- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life changing therapies for people living with gastrointestinal (GI) and rare diseases, today announced...

Zug, Switzerland – May 22, 2026 – Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin Epiduo Acne Gel (Adapalene 0.1% and...

Tokyo – (May 22, 2026) – Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/NYSE: AZN) Datroway® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic...

FOSTER CITY, Calif.--(BUSINESS WIRE) May 22, 2026 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex (bulevirtide-gmod) 8.5 mg for the treatment...

South San Francisco, CA -- May 15, 2026 -- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza&reg...

Princeton, N.J., May 14, 2026 – Kyowa Kirin, Inc., a wholly owned subsidiary of Kyowa Kirin Co. Ltd., today announced the U.S. Food and Drug Administration (FDA) has approved a dosing update to the Crysvita (burosumab-twza) Prescribing...