FDA Panel Backs Replimune’s Melanoma Drug After Multiple Rejections
FDA panel votes 10-3 for Replimune’s RP1 melanoma drug after two rejections, citing benefits for resistant patients despite messy data.
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Karyopharm Shares Plunge After Selinexor Misses in Endometrial Cancer Trial
Karyopharm seeks accelerated FDA approval for selinexor combined with ruxolitinib—the potential first novel combo therapy for myelofibrosis patients.
Johnson & Johnson Cuts 2026 Earnings Outlook on $1 Billion Acquisition Costs
Johnson & Johnson cuts 2026 adjusted EPS guidance to $10.96–$11.11 after its $1B Firefly Bio acquisition and Sail Biomedicines partnership.
MiMedx Buys Sanara MedTech to Nearly Double Surgical Revenue
MiMedx agrees to buy Sanara MedTech for $35/share in a $350M cash-and-stock deal to nearly double surgical revenue. 2027 sales seen over $400M.
FDA Panel Votes 9-3 Against Capricor’s Duchenne Heart Therapy Over Weak Evidence
Final decision due Aug. 22.
FTC Sues Hims & Hers for Sharing Health Data with Meta and Snap
FTC, Utah and California sue Hims & Hers for sharing users’ health data with Meta and Snap despite privacy promises, plus deceptive billing.