FDA approval

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.

UniQure faces class action lawsuit over alleged FDA disclosure misrepresentations. Investors have until April 13, 2026 deadline to join litigation.

Law firm sues uniQure for allegedly misrepresenting gene therapy trial status and FDA approval timeline, causing stock to surge 250% then fall 49% after FDA reversal.

Artios Pharma appoints three senior executives to strengthen manufacturing, clinical operations, and medical affairs as it advances late-stage oncology trials.

uniQure faces securities lawsuit alleging misleading statements about AMT-130's FDA pathway. Stock dropped 49% after FDA reversed stance. Investors have April deadline for lead plaintiff claims.

Rosen Law Firm files securities class action against Inovio Pharmaceuticals for allegedly making false statements about manufacturing deficiencies and regulatory prospects between October 2023 and December 2025.

Rosen Law Firm sued uniQure for allegedly misleading investors about FDA approval timelines and regulatory study status between September-October 2025.

CRISPR Therapeutics eyes growth from Casgevy commercialization and pipeline expansion. FDA-approved gene therapy generates revenue while multiple clinical programs advance toward 2026 milestones.

Inovio Pharmaceuticals faces class action lawsuit for allegedly misleading investors about device manufacturing capabilities and regulatory delays, leading to 24% stock decline.