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HIMS near 52-week low as FDA issues 30 GLP-1 warning letters
FDA sends 30 warning letters to GLP-1 compounders, targeting Hims & Hers Health (HIMS) as regulatory and legal pressure intensifies. Read what it means for investors and the sector.
Why Scholar Rock believes apitegromab could still become a major SMA therapy despite FDA delays
Scholar Rock targets a 2026 BLA resubmission and potential launch for apitegromab in spinal muscular atrophy. Discover what it means for the SMA market.
Vanda Pharmaceuticals (VNDA) wins FDA’s first formal drug approval hearing in 40 years as Hetlioz jet lag battle enters new phase
FDA grants Vanda Pharmaceuticals a rare Part 12 public hearing on Hetlioz jet lag rejection, the first such drug approval hearing in 40 years. Read the full analysis.
What Moderna Inc.’s settlement with Arbutus Biopharma Corporation means for the future of mRNA medicines
Moderna stock surged after hours after settling a $2.25B patent dispute with Arbutus Biopharma and Genevant Sciences. Discover what it means for mRNA vaccines.
Antengene–UCB autoimmune deal: Why the $1.1bn ATG-201 partnership could reshape B-cell targeting therapies
Antengene licenses ATG-201 to UCB in a $1.1B autoimmune drug deal. Discover why bispecific antibodies are becoming the next frontier in immunology.
Pfizer-backed Priovant wins FDA priority review for brepocitinib in dermatomyositis
FDA grants priority review to Priovant's brepocitinib NDA for dermatomyositis with a Q3 2026 PDUFA date. Read what this means for Roivant, Pfizer, and the autoimmune market.
Will the United States lose measles elimination status as CDC calls for urgent vaccination?
CDC acting director urges urgent measles vaccination as U.S. cases surge. Discover what this means for public health policy and elimination status.
Theravance Biopharma (NASDAQ: TBPH) drops rare disease drug after Phase 3 failure triggers strategic review
Theravance Biopharma drops its rare disease drug after a Phase 3 failure. Explore what this means for NASDAQ: TBPH and biotech investors.
Is Merck & Co., Inc. embedding artificial intelligence at the core of its oncology strategy through Tempus AI integration?
Merck expands its Tempus AI collaboration to embed artificial intelligence into oncology research. What this means for MRK, TEM, and precision medicine.
uniQure (NASDAQ: QURE) sinks after FDA mandates Phase III trial for Huntington’s therapy AMT-130
uniQure (QURE) plunges after FDA demands a Phase III trial for AMT-130 in Huntington’s disease. What this means for valuation and next steps.