FDA approval

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.

Deerfield Management increases Vera Therapeutics stake to $205.58M as kidney drug atacicept approaches July 7 FDA decision. Stock up 50% annually.

Deerfield Management increased its Celcuity stake by $80.6M in Q4, bringing total position to $170.95M. Stock surged 1,040% amid FDA review of breast cancer drug gedatolisib.

Deerfield Management boosts $PRAX stake to $266M as biotech stock surges 685% annually. Company eyes $20B+ pipeline revenue potential with two FDA applications pending.

Picard Medical's SynCardia Systems showcases its Total Artificial Heart technology on FOX Business, highlighting over 2,100 implants worldwide.

Class action lawsuit filed against Inovio Pharmaceuticals for allegedly making false statements about CELLECTRA device manufacturing and INO-3107 FDA submission timeline between October 2023 and December 2025.

uniQure faces securities lawsuit after FDA rejected AMT-130 approval pathway. Stock plummeted 49% following disclosure. Lead plaintiff deadline: April 13, 2026.

Rosen Law Firm notifies $CORT investors of securities class action alleging misrepresentation of clinical trial data for relacorilant drug and undisclosed FDA concerns.

BridgeBio reports positive Phase 3 results for BBP-418, showing 31-second improvement in walking tests. FDA submission expected H1 2026, potential U.S. launch late 2026/early 2027.

Law firm Bragar Eagel & Squire files class action lawsuits against $NAVAN and $COPT alleging material misstatements, citing 60%+ and 50%+ stock declines respectively.

Schall Law Firm seeks investors in $COPT securities class action, alleging false statements about relacorilant FDA approval prospects between October 2024 and December 2025.

$VERX surges 6.3% after kidney drug povetacicept achieves Phase 3 trial success with 52% proteinuria reduction, positioning FDA approval by year-end.

Telix Pharmaceuticals' TLX591-Tx meets Phase 3 safety objectives in prostate cancer trial, advancing toward U.S. expansion with FDA.