Posts

Apnimed secures $192M upsized IPO to launch sleep apnea pill Oxnimbi

Oral GLP-1 Tracker: Foundayo and Wegovy Pill Reach New Heights in Obesity Treatment Market

Xpovio mulligan in endometrial cancer misses primary endpoint while Karyopharm presses on in myelofibrosis

Replimune’s Twice‑Rejected Melanoma Drug Prevails in FDA Adcomm Vote

Friday Five: Freenome's CRC Test Wins FDA Nod

VoxNeuro Gains FDA 510(k) Clearance for Cognitive Function Neuroimaging (cfNI) Software

Insilico Medicine Receives FDA Fast Track Designation for AI-Driven Pan-TEAD Inhibitor ISM6331 in Advanced Mesothelioma

ThinkSono Receives FDA Clearance for Ultrasound AI Software for Blood Clots

FDA disputes Capricor's claims of Phase 3 success for DMD cell therapy, deramiocel

Altimmune’s Next-Gen GLP-1 Curbs Heavy Drinking in Unequivocal Phase 2 alcohol use disorder win

MannKind Receives FDA Approval for Furoscix ReadyFlow Autoinjector for Edema in Heart Failure and CKD

FDA's re‑evaluation of Capricor and Replimune drugs underscores that review ≠ reversal

FDA Staff Signal Replimune RP1 Melanoma Trial Failure, Slashing Stock

Apnimed Targets Up to $160M IPO for Sleep Apnea Drug Oxnimbi Launch

Yarrow begins trading as it advances Graves’ disease and thyroid eye disease program

Capricor Shares Plunge After FDA Says DMD Therapy Lacks Efficacy Ahead of Advisory Committee Meeting

FDA Approves Otsuka's Tool SIMTRIYO

FDA Adcomm Backs Popular Wellness Peptides Despite Staff Concerns

Amgen Submits Extensive Data Package to FDA in Defense of Tavneos Approval

Emideltide narrowly voted down by FDA peptide advisory panel on Day 2