Parsippany, NJ, February 5, 2026 – IBSA USA, the U.S. subsidiary of the Swiss pharmaceutical company IBSA, announced today that the Food and Drug Administration (FDA) has approved Vybrique, the first sildenafil oral film available to treat men...

PLAINSBORO, N.J., February 4, 2026 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Ozempic® (semaglutide) tablets 1.5 mg, 4 mg, and 9 mg as the name for oral semaglutide 1.5 mg, 4 mg, and 9 mg...

LONDON, U.K. and SEATTLE, Wash., January 28, 2026 – Tenpoint Therapeutics, Ltd., a global, commercial biotechnology company focused on developing groundbreaking treatments to improve vision in the aging eye, today announced that the U.S. Food...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Jan. 26, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for...

HORSHAM, Pa., January 27, 2026 – Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and...

JERSEY CITY, N.J.--(BUSINESS WIRE) January 16, 2026 -- Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that the US Food and Drug Administration...

On Dec. 23, 2025, the U.S. Food and Drug Administration approved Cablivi (caplacizumab-yhdp) for injection to treat pediatric patients 12 years and older with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange...

BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma...

BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today...

WASHINGTON, Dec. 30, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Nereus (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the...

Planegg-Martinsried, Germany - December 23, 2025 – Formycon AG (FWB: FYB, Prime Standard, “Formycon”) and Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) has approved Nufymco®1...

SEATTLE--(BUSINESS WIRE)--Dec. 24, 2025-- Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) has approved Yartemlea (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated...

Barcelona, Spain, December 19, 2025 - Grifols, a global healthcare company and leading producer of plasma-derived medicines, today announced that its fibrinogen concentrate, Fesilty (fibrinogen, human-chmt), has been approved by the U.S. Food and...

CAMBRIDGE, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that the U.S...

South San Francisco, CA -- December 21, 2025 -- Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio Velo (mosunetuzumab-axgb), as a subcutaneous (SC)...

London, UK, 22 December 2025: Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, announces that the US Food and Drug Administration (FDA), following a priority review of the clinical...

WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., December 23, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced two business updates—approval of the Furoscix (furosemide) On-body Infusor for pediatric patients and...

PLAINSBORO, N.J., Dec. 22, 2025 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved once-daily Wegovy pill, the first oral GLP-1 medicine for obesity in the US.3 Wegovy pill is used with a reduced...

Ingelheim, Germany/Ridgefield, Connecticut, December 19, 2025 -- Boehringer Ingelheim’s Jascayd (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of progressive pulmonary fibrosis (PPF)...