FDA approval

Novo Nordisk wins FDA approval for Wegovy HD, a higher-dose version launching in April across 70,000+ U.S. pharmacies, despite modest stock decline.

Class action lawsuit filed against $UQRR alleging materially false statements about FDA approval and BLA timeline delays. Investors urged to join by April 13, 2026 deadline.

Institutional investors rotate capital to precision oncology biotech as patent cliff pressures Big Pharma. Five clinical-stage companies positioned for M&A amid $303B market opportunity.

Portnoy Law Firm files class action against $AQST for allegedly misleading investors about Anaphylm FDA prospects. Stock plunged 37% after deficiency disclosure.

FDA approves Icotyde for psoriasis, triggering $50M payment to Protagonist. Market reacts with AbbVie stock falling 5.20% amid competitive pressure.

Taysha Gene Therapies reported $109M 2025 loss while advancing TSHA-102 gene therapy for Rett syndrome with positive safety data and FDA regulatory alignment through 2028.

Roche's Ionify® steroid assays receive FDA's moderate complexity designation, expanding access to mass spectrometry-based hormone testing across routine clinical laboratories.

Corcept Therapeutics faces securities fraud lawsuit after FDA rejected relacorilant. Stock crashed 50% following misleading investor claims about approval prospects.

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.