fda-and-biotech News
Moderna surges after FDA reverses course on flu vaccine review
Regulatory agency will review mRNA-1010 after surprise about-face, PDUFA set for August 2026
Harmony Biosciences shares jump 2.8% after FDA approves pediatric Wakix
First and only non-scheduled treatment for children with narcolepsy expands addressable market
Disc Medicine shares plunge 28% after FDA rejects bitopertin approval
Agency requires Phase 3 APOLLO trial data by late 2026, pushing potential approval to mid-2027
Novocure surges on FDA approval of Optune Pax for pancreatic cancer
Tumor-treating fields therapy expands into third indication, potentially opening multi-billion dollar market opportunity
uniQure slides 2.9% as class action lawsuits mount over FDA rejection
Gene therapy company faces legal scrutiny after November regulatory setback crushed shares 49%
Moderna falls after FDA refuses to review flu vaccine application
Regulatory setback for mRNA-1010 seasonal influenza shot comes as biotech company faces declining revenue and pipeline diversification challenges
Hims & Hers plunges on FDA crackdown over unapproved weight-loss drugs
Regulatory action threatens telehealth company's key growth driver amid DOJ referral
uniQure falls 8% on Fabry gene therapy safety concerns, efficacy data
AMT-191 trial shows strong enzyme activity but dose cohorts paused after liver toxicity, stroke