FDA approval

Gilead acquires Arcellx for $7.8B to gain CAR-T therapy anito-cel for multiple myeloma, with FDA approval expected by late 2026.

Inovio Pharmaceuticals faces FDA rejection of its lead drug candidate and mounting cash constraints, raising questions about the biotech firm's long-term viability without revenue-generating products.

Novo Nordisk shares plunged 13% after CagriSema obesity drug trial missed non-inferiority target versus Eli Lilly's tirzepatide, threatening competitive positioning.

Perceptive Advisors doubles investment in Praxis Precision Medicines to $588M, now largest holding. Stock surges 320% amid FDA submissions and strong cash position.

Perceptive Advisors doubled its Celcuity stake to 5.62% of AUM, making it the fund's second-largest holding. Stock surged 700% YoY ahead of expected FDA approval for lead drug Gedatolisib.

Medtronic offers defensive stability through 48 years of dividend increases, essential medical devices, and consistent profitability across economic cycles.

Inovio Pharmaceuticals faces securities lawsuit alleging false statements about its CELLECTRA device and regulatory prospects. Investors who purchased stock between October 2023-December 2025 may qualify for compensation.

Large-cap stocks rallied on strong earnings and corporate actions. First Majestic Silver led with 25% gains, joined by Moderna and Global Payments on positive results.

uniQure faces securities class action over allegedly misleading FDA approval claims and timeline delays. Investors must act before April 13, 2026 deadline.

Securities fraud lawsuit filed against uniQure for allegedly making false statements about FDA approval processes and BLA submission timelines, causing investor losses.

FDA accepts Teva's application for monthly olanzapine injection treating schizophrenia. The formulation eliminates post-injection monitoring requirements while maintaining efficacy.

CRISPR Therapeutics gains FDA approval for Casgevy, its first gene-editing therapy for rare blood disorders, validating the platform with multiple pipeline candidates in development.

FDA approves first all-oral combination therapy for untreated chronic lymphocytic leukemia. The fixed-duration treatment showed 35% reduced progression risk versus chemotherapy.

Eli Lilly's Omvoh shows durable three-year remission in Crohn's disease, with 92.4% of patients maintaining clinical remission and reduced hospitalizations compared to placebo.

Aquestive to present clinical trial data for Anaphylm, an investigational oral anaphylaxis treatment, at 2026 allergy conference, showing promising safety and efficacy results.

uniQure faces securities class action lawsuit over allegedly false FDA approval statements. Investors who purchased stock between September-October 2025 can join the case by April 2026.

Rosen Law Firm files class action lawsuit against Inovio Pharmaceuticals for allegedly misrepresenting manufacturing capabilities and overstating product development prospects, urging investors to act before deadline.

Candel Therapeutics raises $100M via public share offering to fund commercialization of its prostate cancer gene therapy and ongoing lung cancer clinical trials.

Class action lawsuit alleges uniQure withheld FDA study design concerns from investors, causing 49% stock decline after disclosure in November 2025.

uniQure faces class action lawsuit alleging misleading FDA approval statements and understated BLA timeline risks. Investors who purchased securities between September-October 2025 may be eligible to participate.