MindMed Presents Alarming Data on Suicidal Ideation Among Adults with Generalized Anxiety Disorder at Psych Congress 2025 Researchers from Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), a late-stage clinical biopharmaceutical company pioneering the development of novel product candidates for brain health…
Merck Secures Dual Positive CHMP Opinions for KEYTRUDA® in Europe: Subcutaneous Administration and New Head & Neck Cancer Indication Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced a major regulatory milestone in Europe as…
Intellia Therapeutics Completes Enrollment in the Global Phase 3 HAELO Study of Lonvoguran Ziclumeran (lonvo-z) for Hereditary Angioedema Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced it has completed enrollment…
Biogen Receives European Commission Approval for ZURZUVAE® (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted marketing authorization for ZURZUVAE® (zuranolone) to treat post-partum…
Deciphera Receives European Commission Approval of ROMVIMZA™ (vimseltinib) for the Treatment of Tenosynovial Giant Cell Tumor (TGCT) Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced that the European Commission (EC) has approved ROMVIMZA™…
FDA Takes Long Overdue Baby Step Toward Regulating Compounder Drug Ads A complex state vs. federal regulatory scheme allows drug compounders to advertise drugs without disclosing risks like a pharma company must do. Experts say it’s time for the FDA…
Novo, Lilly Jostle For Market Lead in Obesity With New Regulatory Efforts Both Novo Nordisk and Eli Lilly are eyeing regulatory advancements for their obesity blockbusters as the European Association for the Study of Diabetes’ annual conference continues this week.…
Sanofi Joins Growing Group of Pharmas Pulling Back From UK Merck, Eli Lilly and AstraZeneca have similarly suspended or outright canceled investments in the U.K. in the past week after a sizeable increase in a mandatory levy in the region…
FDA grants Breakthrough Therapy Designation to Raludotatug Deruxtecan for CDH6+ platinum-resistant ovarian and related cancers previously treated with bevacizumab Raludotatug deruxtecan (R-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment…
EU approves first oral GLP-1 RA to cut cardiovascular risk Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the Rybelsus® (oral semaglutide) label to reflect the cardiovascular…
People taking Novo Nordisk’s Wegovy® experienced reduced food noise and boosted mental well-being Novo Nordisk today announced results from the US-based INFORM survey of people taking semaglutide for weight management (Wegovy®), at the European Association for the Study of Diabetes…
Zoetis Receives Positive Opinion from CVMP for Portela® (relfovetmab) to Alleviate Pain Associated with Osteoarthritis in Cat Zoetis Inc. today announced that the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending…