fda-and-biotech News
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
Relay Therapeutics jumps 7% on FDA Breakthrough Therapy designation for breast cancer drug
Zovegalisib targets 40% of HR+/HER2- patients with PIK3CA mutations in underserved post-CDK4/6 market
AstraZeneca faces FDA rejection on Saphnelo lupus injection
Regulator issues Complete Response Letter for subcutaneous formulation as resubmission targets H1 2026 decision
Pharming shares plunge 16% after FDA rejects pediatric Joenja expansion
Regulators flagged dosing concerns and analytical issues, but existing approval for patients 12 and older remains intact
Aquestive shares fall on FDA Complete Response Letter for Anaphylm
Packaging and administration issues cited; resubmission expected Q3 2026
MannKind shares rise after FDA clears Afrezza label update
New dose conversion guidance for switching from injectable insulin could simplify prescribing and boost adoption of inhaled therapy
Guardant Health Stock Hits 52-Week High on Key FDA Approval
The regulator cleared Guardant's liquid biopsy as a companion diagnostic for a Pfizer colorectal cancer therapy, cementing a critical link between the test and treatment.