FDA approval

Rosen Law Firm seeks lead plaintiffs in securities class action against Corcept Therapeutics, alleging misrepresentation of FDA communications and clinical trial data for relacorilant drug.

Pomerantz Law Firm files class action against $INO for alleged securities fraud involving false manufacturing capability and FDA approval claims for INO-3107.

Class action lawsuit filed against Corcept Therapeutics alleges material misstatements about relacorilant drug trials and regulatory approval prospects, covering investors from October 2024 through December 2025.

Pfizer reports positive Phase 2 data for atirmociclib in metastatic breast cancer, meeting survival endpoints. Company also gains FDA approval for Braftovi in colorectal cancer.

Edgewise Therapeutics pursues two major drug candidates addressing unmet cardiac and muscular disease needs, with pivotal data expected through 2026.

BioCardia wins FDA acceptance of pre-submission package for Helix transendocardial delivery catheter, advancing minimally invasive cardiac therapy platform.

Vestal Point Capital sold $103.93M in Nuvalent shares, reducing exposure despite company's 30% rally and $1.4B cash position awaiting 2026 FDA decisions.

Cormorant Asset Management sold $PRAX shares for $9.3M in Q4, yet position surged $227M in value. Stock remains fund's largest holding at $280M.

$AQST plummets 37% after FDA rejects Anaphylm application. Investors sue over alleged misleading statements about approval prospects.

$COGT surges 5.24% after FDA accepts bezuclastinib NDA for Non-Advanced Systemic Mastocytosis, with decision expected by December 2026.

Class action lawsuit filed against $AQST alleging misleading statements about FDA approval timeline for Anaphylm and concealed human factors risks.

Inovio Pharmaceuticals faces class action securities fraud lawsuit alleging false statements about manufacturing capabilities and regulatory timelines. Investors have until April 7, 2026 to join.

Novartis wins FDA approval for Cosentyx in pediatric hidradenitis suppurativa patients aged 12+, marking the drug's fourth pediatric indication and expanding its dermatology portfolio.

Eli Lilly's Ebglyss shows strong efficacy in pediatric atopic dermatitis trial, with 63% achieving significant skin clearance. Company plans regulatory submission for label update.

Structure Therapeutics reports Phase 2 data for oral GLP-1 agonist aleniglipron showing 16.3% weight loss, matching injectable competitors with better tolerability.

Greenwich LifeSciences deploys commercially manufactured GP2 across all 40 FLAMINGO-01 trial sites following FDA approval, scaling production capacity significantly.

Class action lawsuit filed against $QURE over alleged misstatements about Huntington's disease therapy approval timeline. Stock crashed 49% after FDA stance shift.

Aquestive Therapeutics faces securities class action over alleged false FDA approval statements for Anaphylm drug. Stock fell 37% after January 2026 NDA rejection.

GSK's Arexvy RSV vaccine gains FDA approval for younger high-risk adults aged 18-49, expanding market beyond 60+ population on strong Phase 3b data and £198M Q4 sales.

Class action lawsuit filed against $CORP alleging executives made false statements about relacorilant's clinical strength and FDA approval prospects.