FDA approval

Eton Pharma gains FDA approval for DESMODA, the first liquid desmopressin formulation for central diabetes insipidus, launching March 9 with projected peak sales of $30-50 million.

Pfizer's Braftovi receives full FDA approval for treating BRAF-mutated metastatic colorectal cancer when combined with cetuximab and chemotherapy, based on Phase 3 trial data.

Moderna shifts from pandemic revenues toward diversified pipeline including seasonal vaccines and oncology treatments, targeting cash breakeven by 2028 amid FDA progress on flu vaccine candidate.

Grace Therapeutics will present at TD Cowen conference in March 2026. FDA sets April 2026 review date for GTx-104 aneurysmal subarachnoid hemorrhage treatment.

Geron's RYTELO generated $184M in 2025 revenue. The company guides 2026 sales of $220-240M, driven by domestic expansion and international opportunities.

Immuron lifted H1 revenue 5% to AUD$4.2M with strong U.S. growth of 17%. The company secured AUD$7.3M funding and is pursuing partnerships to advance its clinical pipeline.

uniQure faces securities fraud lawsuit after FDA rejected its drug candidate AMT-130, causing a 49% stock plunge. Plaintiffs allege the company failed to disclose material information to investors.

Corcept Therapeutics faces securities fraud lawsuit for failing to disclose FDA setback on relacorilant drug, causing 50% stock decline.

Law firm files securities fraud lawsuit against BellRing after 52% stock plunge, alleging failure to disclose inventory and supply chain issues.

Cytokinetics launches MYQORZO for heart disease post-FDA approval; guides $830-870M spending in 2026 with strong cash position supporting commercial expansion.

FDA approves Dupixent for allergic fungal rhinosinusitis in patients six and older, marking the drug's ninth indication for treating type 2 inflammatory conditions.

Clene outlines 2026 regulatory milestones for ALS drug CNM-Au8, including FDA meeting, NDA submission, and Phase 3 trial, backed by $28 million funding.

Nicox's NCX 470 eye drop met primary efficacy endpoints in Phase 3 glaucoma trials, showing superior IOP reduction versus standard treatment with favorable safety profile.

Palvella to present Phase 3 SELVA trial results for QTORIN gel treating lymphatic malformations on February 24, 2026, with data release at 6:30 a.m. ET.

Beam Therapeutics will discuss 2025 results and unveil a new liver disease program on February 24, 2026. The company also secured FDA alignment for accelerated approval of BEAM-302.

Neuromodulation device market expected to double to $16.1 billion by 2032, driven by rising neurological diseases, technological advances, and regulatory support.

uniQure faces class action lawsuit alleging misleading statements about FDA study status and BLA timeline delays. Investors who purchased shares Sept-Oct 2025 may be eligible to claim.

Gilead acquires Arcellx for $7.8B to expand CAR-T therapy portfolio, strengthening oncology pipeline and cell therapy capabilities.

Commodore Capital cuts $84M Nuvalent stake to 3.68% despite 29% stock gains. Biotech firm awaits September PDUFA decision for lead drug candidate.

Teva's once-monthly schizophrenia injection TEV-749 advances toward FDA approval, aiming to improve patient medication compliance and reduce healthcare burden compared to daily oral treatments.