FDA approval

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.

Class action lawsuit filed against Inovio Pharmaceuticals for allegedly making false statements about device manufacturing capabilities and regulatory timelines between October 2023 and December 2025.

Merck's RSV antibody Enflonsia shows positive Phase 3 results, supporting FDA expansion plans to protect more at-risk infants from respiratory syncytial virus infection.

uniQure faces securities lawsuit over failing to disclose that FDA rejected its gene therapy candidate AMT-130, causing stock to plunge 49%. Lead plaintiff deadline set for April 13, 2026.

FDA accepts Moderna's flu vaccine application after prior rejection, setting August priority review date. Stock surges 5.77% as company expands mRNA pipeline beyond COVID-19.

Over 40 companies develop 50+ CTLA-4 inhibitor candidates for cancer immunotherapy. Recent FDA approvals and focus on combination strategies drive pipeline expansion.

Staar Surgical wins FDA approval to expand implantable lens eligibility to patients aged 21-60, up from 21-45, potentially reaching 8 million additional U.S. candidates.

Schall Law Firm launches class action against Inovio Pharmaceuticals for alleged misrepresentations about manufacturing capabilities and regulatory timelines. Investors can join until April 7, 2026.

J&J's lung cancer therapy Rybrevant Faspro gains FDA approval for accelerated monthly dosing, maintaining efficacy while improving patient convenience and reducing treatment burden.

Compass Pathways stock surged 44% after positive Phase 3 trial results for psilocybin depression therapy. FDA application expected by end of 2024.

Biotech firms advance treatment-resistant cancer therapies across multiple platforms, including oncolytic viruses and cellular immunotherapy, with several candidates achieving regulatory milestones and encouraging clinical data.

Rosen Law Firm sues Inovio Pharmaceuticals for allegedly making false statements about manufacturing capabilities and regulatory timelines, causing investor losses through inflated stock prices.

Securities lawsuit against uniQure alleges misleading FDA disclosure statements about gene therapy candidate AMT-130. Stock fell 49% after November FDA feedback; investors must file claims by April 13, 2026.