Risk
FDA delays decision date on Cytokinetics’ heart drug to year-end in unusual safety program back-and-forth
Cytokinetics, aficamten, FDA delay, PDUFA date extension, hypertrophic obstructive cardiomyopathy (oHCM), Risk Evaluation and Mitigation Strategy (REMS), regulatory setback
UK approval brings GSK’s Blenrep back from the brink
UK, Approved, Multiple Myeloma, DREAMM-8, dexamethasone, Blenrep, Antibody-Drug Conjugates, Risk, Cessation of life
ViiV Healthcare’s Multifaceted Approach to Combating HIV in Black Communities
ViiV Healthcare, HIV prevention, Black communities, Risk to Reasons, community grants, stigma reduction, education, access to care
FDA Approves Ozempic for Reducing Kidney Disease Risks in Adults with Type 2 Diabetes and Chronic Kidney Disease
Ozempic, FDA Approval, Type 2 Diabetes, Chronic Kidney Disease (CKD), Kidney Disease Risks, Cardiovascular Disease Risks, Semaglutide, GLP-1 Receptor Agonist
Takeda to Discontinue Uloric: A Gradual Decline of the Gout Medication
Takeda, Uloric, gout medication, discontinuation, cardiovascular risks, FDA scrutiny
FDA Adds Boxed Warning to Teva’s Copaxone and Generic Glatopa Due to Anaphylaxis Risk
FDA Boxed Warning, Anaphylaxis Risk, Copaxone, Glatopa, Glatiramer Acetate, Multiple Sclerosis (MS) Treatment, Allergic Reaction
FDA Halts Pediatric RSV Vaccine Trials Due to Safety Concerns
RSV vaccines, pediatric trials, safety concerns, FDA hold, VAERD risk
Cyclacel Pharmaceuticals Seeks Financial Lifeline Amidst Cash Crunch
Cyclacel Pharmaceuticals, financial challenges, cost reduction, strategic alternatives, Nasdaq delisting risk, cancer medicine development
Breakthrough in Heart Disease Treatment: Lilly’s Muvalaplin and Silence Therapeutics’ Zerlasiran Show Promising Results in Lowering Lipoprotein(a) Levels
Lipoprotein(a) (Lp(a)), Heart Disease, Muvalaplin, Zerlasiran, Cardiovascular Risk, Gene Silencing Therapy, RNA Interference, Atherosclerotic Cardiovascular Disease
Lilly’s Muvalaplin Shows Promising Results in Reducing Lipoprotein(a) Levels in Adults at High Risk for Cardiovascular Events
Muvalaplin, Lipoprotein(a) [Lp(a)], Cardiovascular risk, Oral drug, Phase II trial, Eli Lilly, Cholesterol reduction