FDA approval

DBV Technologies announced strong Phase 3 data for VIASKIN® Peanut patch, with 82.8% of treated children showing improved tolerance. FDA submission planned for H1 2026.

DBV Technologies' peanut allergy patch met Phase 3 goals with 46.6% responder rate versus 14.8% placebo, supporting planned 2026 FDA submission.

Medtronic gains FDA approval for Hugo robotic surgery system and spins off diabetes division, strengthening market position while reporting 8.7% revenue growth and maintaining 48-year dividend streak.

Exelixis secures FDA approval for zanzalintinib and expands beyond cabozantinib with robust pipeline, posting 57.9% EPS growth while advancing multiple Phase 3 trials.

Ascendis Pharma wins FDA approval for YUVIWEL, the first once-weekly treatment for pediatric achondroplasia. The therapy offers improved dosing convenience over existing options.

Rosen Law Firm sues Corcept Therapeutics for allegedly making misleading statements about clinical trial data and FDA approval prospects for its relacorilant drug candidate.

BMS's Sotyktu shows promise for psoriatic arthritis among one-third of surveyed rheumatologists, but analysts expect modest market capture ahead of March 2026 FDA decision.

Corcept Therapeutics faces securities lawsuit alleging misrepresentation of relacorilant clinical data and FDA approval prospects, while withholding known regulatory risks from investors.

Mesoblast reports strong H1 results with Ryoncil® revenue of $51.3M and narrowed net losses. Commercial expansion underway with 49 transplant centers operational and FY2026 guidance of $110-120M revenue.

UniQure faces securities lawsuit alleging material misrepresentations about its Huntington's Disease trial design and FDA approval status. Lead plaintiff deadline is April 13, 2026.

Anteris secures $320M funding to advance DurAVR heart valve through global trials, with FDA approval and increased clinical development spending.

Psilocybin gains regulatory momentum with first Phase 3 success in treatment-resistant depression. DEA increases production quota 67%, while five pharma companies advance psychedelic programs across multiple CNS indications.

Argenx's VYVGART achieves Phase 3 success for ocular myasthenia gravis, meeting primary endpoint. Company plans FDA application to expand indication for the rare eye disorder treatment.

ImmunityBio completed Phase 3 cancer trial enrollment ahead of schedule with strong 85% response rates. Anktiva sales surged 750% year-over-year, hitting $38.29M in revenue.

BioCryst achieved historic profitability with ORLADEYO revenue surging 38% to $601.8 million. FDA approval for pediatric formulation and Astria acquisition expand HAE treatment portfolio.

argenx's VYVGART met its primary endpoint in a Phase 3 ocular myasthenia gravis trial, showing significant symptom improvements. The company plans FDA approval for label expansion.

uniQure faces class action lawsuit over failing to disclose FDA rejection of AMT-130 drug candidate, causing 49% stock decline. Lead plaintiff deadline: April 13, 2026.

Class action lawsuit filed against uniQure for allegedly making false statements about FDA approval status and BLA submission timelines, misleading investors.

Arcutis reported 2025 revenue of $372.1M (123% growth) and raised 2026 guidance to $480-495M, driven by strong ZORYVE adoption and positive clinical data.

BVF Partners invests $52M in Disc Medicine despite FDA setbacks, betting on Phase 3 trial data and strong cash reserves through 2029.