FDA approval

170 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

uniQure Investors Face April Deadline in Securities Litigation Over FDA Disclosure Claims

UniQure faces class action lawsuit over alleged FDA disclosure misrepresentations. Investors have until April 13, 2026 deadline to join litigation.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Kessler Topaz Meltzer & Check, Llp

Securities Litigation Filed Against uniQure Over Gene Therapy Trial Misstatements

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.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Not Specified

Artios Pharma Bolsters Executive Ranks Ahead of Late-Stage Oncology Trials

Artios Pharma appoints three senior executives to strengthen manufacturing, clinical operations, and medical affairs as it advances late-stage oncology trials.
LLYJAZZFDA approvalclinical development
GlobeNewswire Inc.GlobeNewswire Inc.··Faruqi & Faruqi, Llp

QURE Investors Face April Deadline in Securities Class Action Over AMT-130 Claims

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.
QUREsecurities class actionmisleading statements
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Rosen Law Firm Files Securities Class Action Against Inovio Pharmaceuticals

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.
INOsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Class Action Lawsuit Filed Against uniQure Over FDA Approval Disclosures

Rosen Law Firm sued uniQure for allegedly misleading investors about FDA approval timelines and regulatory study status between September-October 2025.
QUREsecurities fraudclass action lawsuit
The Motley FoolThe Motley Fool··Adria Cimino

CRISPR Therapeutics Poised for Growth on Casgevy Momentum and Pipeline Expansion

CRISPR Therapeutics eyes growth from Casgevy commercialization and pipeline expansion. FDA-approved gene therapy generates revenue while multiple clinical programs advance toward 2026 milestones.
VRTXCRSPFDA approvalclinical trials
GlobeNewswire Inc.GlobeNewswire Inc.··Robbins Llp

Inovio Pharmaceuticals Faces Class Action Over Device Manufacturing Disclosures

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

Citius Oncology Posts Maiden Revenue of $3.9M From LYMPHIR Launch

Citius Oncology reports maiden revenue of $3.9M from LYMPHIR immunotherapy launch in December 2025, marking transition to commercial-stage biopharmaceutical company.
CTXRCTORnet lossFDA approval
BenzingaBenzinga··Namrata Sen

Eli Lilly Stockpiles $1.5B in Experimental Weight-Loss Drug Ahead of FDA Review

Eli Lilly stockpiles $1.5B of experimental weight-loss drug orforglipron ahead of expected April FDA approval decision, signaling management confidence.
LLYNVOFDA approvalpharmaceutical competition