FDA approval

FDA expands VYVGART approval to include seronegative myasthenia gravis patients, broadening treatment access and increasing commercial opportunity for Ultragenyx.

Alpha Tau Medical completes enrollment of 88 patients in pivotal skin cancer trial, advancing toward FDA approval of Alpha DaRT® for recurrent squamous cell carcinoma.

Pharvaris raises $115M through 3.87M share offering at $29.68 per share to advance oral angioedema treatments; Phase 3 data expected Q3 2026.

FDA extends LEQEMBI IQLIK subcutaneous review to August 2026 without raising approvability concerns, maintaining regulatory momentum for Eisai and Biogen's reformulated Alzheimer's treatment.

Glucotrack submits IDE application for FDA clinical trial of implantable continuous glucose monitoring technology, marking major regulatory milestone for diabetes care innovation.

ARS Pharmaceuticals ($SPRY) schedules May 15 earnings call to discuss Q1 2026 results and neffy® nasal spray commercialization progress across U.S., EU, and China markets.

22nd Century reports Q1 revenue of $4.1M, plans to expand VLN® cigarettes to 5,000 retail stores by year-end while maintaining $9.5M cash and zero debt.

Oculis secures FDA agreement on Phase 3 trial design for Privosegtor optic neuritis treatment, de-risking regulatory pathway and clearing way for future drug submission.

Oculis secures FDA Special Protocol Assessment for Privosegtor Phase 3 trial, de-risking path to potential $7 billion optic neuritis market.

Arcutis reports Q1 2026 ZORYVE revenue of $105.4 million, up 65% year-over-year, with expanded pediatric development and reaffirmed full-year guidance of $480-495 million.

Novo Nordisk reported Q1 2026 adjusted operating profit of DKK 32.9B, raising 2026 guidance on Wegovy® pill's success with 2M total prescriptions since January launch.

Class action lawsuit filed against Atara Biotherapeutics alleges false statements about FDA approval prospects. Investors must seek lead plaintiff status by May 22, 2026.

Eli Lilly reports durable four-year efficacy data for Omvoh in IBD, with 63.5% ulcerative colitis remission and 92.4% Crohn's response rates, bolstering pipeline confidence.

Axsome Therapeutics to present at BofA Securities and RBC Capital Markets healthcare conferences in May 2026, with webcast access for remote investors.

Arvinas wins landmark FDA approval for VEPPANU, first PROTAC protein degrader for breast cancer, ahead of schedule. Reports Q1 2026 results May 12.

FDA approves VEPPANU, first PROTAC therapy for advanced breast cancer with ESR1 mutations, showing 43% reduction in disease progression risk versus existing treatment.

Rosen Law Firm urges $ATRA investors to meet May 22, 2026 deadline in securities lawsuit alleging false statements about manufacturing and clinical trial deficiencies.

Eli Lilly beats Q1 earnings, raises $2B guidance, and wins FDA approval for Foundayo, the first unrestricted oral GLP-1, widening gap over Novo Nordisk.

Arvinas and Pfizer secure FDA approval for VEPPANU, the first PROTAC protein degrader, for ESR1-mutated breast cancer based on Phase 3 data showing 43% progression-risk reduction.

AstraZeneca's prostate drug Truqap wins FDA panel backing (7-1 vote) for PTEN-deficient tumors, but breast cancer candidate camizestrant rejected despite superior efficacy data.