FDA approval

FDA approves Dupixent for children ages 2-11 with chronic spontaneous urticaria, marking first biologic treatment for this pediatric population.

FDA approves Dupixent for children ages 2-11 with uncontrolled chronic spontaneous urticaria, marking first biologic treatment for this pediatric population.

Madrigal Pharmaceuticals reports Q1 2026 results May 6, revealing early commercial performance of FDA/EMA-approved MASH treatment Rezdiffra following recent regulatory clearances.

Sanofi seeks FDA approval for first on-body injector cancer therapy; decision extended to July 2026. Tzield pediatric indication also expanded.

FDA approves Sanofi's Tzield for children as young as one with type 1 diabetes, marking first disease-modifying therapy for this young cohort.

FDA approves $SANF's Tzield for children ages 1+ with stage 2 type 1 diabetes, expanding from prior 8+ restriction. First disease-modifying therapy for autoimmune condition.

Belite Bio begins rolling NDA submission to FDA for tinlarebant, a potential breakthrough oral therapy for rare Stargardt disease, targeting 2027 commercialization.

Kopp Family Office exits $3.5M Viridian stake as stock plummets 50% following disappointing Phase 3 data and Amgen's superior competing results.

Merck shares dropped 4% after Phase 3 cancer trial failure, but FDA approval of HIV treatment Idvynso provided partial offset.

Lawsuit filed against $CORT alleging executives made false statements about relacorilant's clinical strength and FDA approval prospects, concealing regulatory concerns.

Class action lawsuit filed against Atara Biotherapeutics alleging false statements about manufacturing issues and regulatory prospects for tabelecleucel.

Agios Pharmaceuticals plunged 23% after Novo Nordisk's superior sickle cell drug trial results overshadowed Agios' failed mitapavit candidate, threatening its commercial viability.

Compass Pathways stock surges 40% following White House Executive Order accelerating FDA approval of its COMP360 psychedelic therapy for treatment-resistant depression.

Class action lawsuit filed against $ATARA alleging executives misled investors about manufacturing issues and study deficiencies affecting tabelecleucel FDA approval prospects.

Eli Lilly received FDA approval for Foundayo weight-loss pill in April 2026. With 40%+ growth and premium valuation, stock needs only 20% gain to hit $1 trillion market cap.

Xenon Pharmaceuticals reports positive Phase 3 data for azetukalner in focal onset seizures, with 53.2% seizure reduction versus 10.4% placebo. FDA submission planned for Q3 2026.

Atara Biotherapeutics faces class action lawsuit alleging false statements about manufacturing and ALLELE study deficiencies. Lead plaintiff deadline set for May 22, 2026.

Theriva Biologics will present expanded VIRAGE trial data for VCN-01 at AACR 2026, with FDA and EMA agreement on Phase 3 design for metastatic pancreatic cancer treatment.

Rosen Law Firm urges Corcept Therapeutics investors with losses exceeding $100K to join securities class action before April 21, 2026 deadline over alleged FDA application misrepresentations.

argenx presents Phase 3 data supporting VYVGART expansion across ocular MG, seronegative MG, and treatment-naïve CIDP, with 87.5% early benefit rates.