FDA

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

Inovio Investors Face April 7 Deadline in Securities Class Action Over Alleged Misstatements

Rosen Law Firm alerts $INO investors of April 7, 2026 deadline to join class action over alleged false statements regarding manufacturing and regulatory prospects.
INOsecurities class actionmisleading statements
GlobeNewswire Inc.GlobeNewswire Inc.··Sanofi And Regeneron

Dupixent Wins Japan Approval for Rare Autoimmune Disorder, Expanding Sanofi-Regeneron Pipeline

Sanofi and Regeneron's Dupixent secured Japanese regulatory approval for bullous pemphigoid, marking the drug's seventh indication in Japan with superior remission rates versus placebo.
SNYREGNclinical trialDupixent
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Inovio Faces Securities Class Action Over Vaccine Device Defects, Regulatory Claims

Rosen Law Firm seeks lead plaintiffs in securities class action against Inovio Pharmaceuticals for alleged misstatements on device defects, regulatory prospects, and product timelines. Lead plaintiff deadline: April 7, 2026.
INOsecurities class actionmisleading statements
GlobeNewswire Inc.GlobeNewswire Inc.··Nrx Pharmaceuticals, Inc.

NRx Pharmaceuticals to Unveil 2025 Results, Update on Breakthrough Psychiatric Drug Pipeline

NRx Pharmaceuticals to report 2025 results March 24, 2026, updating on FDA-designated ketamine and PTSD programs with significant clinical potential.
NRXPNRXPWfinancial resultsclinical-stage biopharmaceutical
GlobeNewswire Inc.GlobeNewswire Inc.··Faruqi & Faruqi, Llp

Inovio Faces Securities Class Action Over Failed FDA Approval Strategy

Inovio Pharmaceuticals faces a securities class action over allegedly false statements regarding manufacturing capabilities and regulatory prospects for INO-3107, following FDA's December 29 accelerated approval rejection.
INOstock declinesecurities class action
BenzingaBenzinga··Glancy Prongay Wolke & Rotter Llp

Soleno Therapeutics Faces Securities Fraud Lawsuit Over DCCR Safety Claims

Class action lawsuit filed against $SLNO over alleged securities fraud tied to DCCR drug safety concerns, patient death, and disappointing Q3 results.
SLNOsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Inovio Faces Securities Class Action Over Device Defects, Missed Regulatory Timelines

Rosen Law Firm files securities class action against Inovio Pharmaceuticals ($INO) alleging misleading statements on manufacturing deficiencies and overstated regulatory prospects. Lead plaintiff deadline April 7, 2026.
INOsecurities class actionmisleading statements
BenzingaBenzinga··Vandana Singh

Eli Lilly Warns of Unknown Impurity in Compounded Weight Loss Drugs

Eli Lilly warns of unidentified impurity in compounded tirzepatide weight loss drugs mixed with vitamin B12, urging FDA recalls and stricter oversight.
LLYweight loss drugsZepbound
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Moleculin Advances MIRACLE Study as Annamycin Shows Promise in AML Treatment

Moleculin Biotech releases CEO update on Phase 3 MIRACLE trial evaluating Annamycin for relapsed/refractory acute myeloid leukemia, with enrollment progressing on schedule.
MBRXclinical developmentPhase 3 trial
GlobeNewswire Inc.GlobeNewswire Inc.··Hagens Berman

Soleno Therapeutics Hit With Class Action Over VYKAT Launch Failures and Safety Disclosures

$SLNO faces securities lawsuit alleging misleading safety claims for hyperphagia drug VYKAT XR. Stock crashed 40% after short seller report and management admissions of launch disruptions.
SLNOsecurities class actionclinical trial
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Inovio Faces Securities Lawsuit Over Manufacturing Claims and Regulatory Missteps

Rosen Law Firm urges $INO investors to join class action lawsuit alleging false statements about manufacturing deficiencies and regulatory prospects.
INOsecurities class actionmisleading statements
GlobeNewswire Inc.GlobeNewswire Inc.··Not Specified

NRx Pharmaceuticals Names TMS Expert as Chief Medical Innovation Officer

NRx Pharmaceuticals appoints Prof. Joshua Brown, leading TMS researcher, as Chief Medical Innovation Officer to advance PTSD and depression treatments for veterans.
NRXPNRXPWclinical trialsFDA
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Inovio Investors Urged to File Claims Before April Deadline in Securities Litigation

Rosen Law Firm notifies Inovio investors of securities class action with April 7, 2026 lead plaintiff deadline, citing alleged false statements on manufacturing and regulatory matters.
INOinvestor lossessecurities class action
GlobeNewswire Inc.GlobeNewswire Inc.··Bragar Eagel & Squire, P.C.

Inovio Pharmaceuticals Faces Class Action Over FDA Rejection and Device Claims

Inovio Pharmaceuticals faces class action lawsuit over alleged false statements regarding manufacturing defects and regulatory prospects after FDA rejected accelerated approval, causing 24% stock decline.
INOclass action lawsuitstock decline
GlobeNewswire Inc.GlobeNewswire Inc.··Faruqi & Faruqi, Llp

REGENXBIO Investors Face April 14 Deadline in Gene Therapy Securities Lawsuit

REGENXBIO faces securities lawsuit over alleged false statements about gene therapy safety. Investors have until April 14 deadline to join class action after FDA clinical hold.
RGNXstock declinesecurities class action
GlobeNewswire Inc.GlobeNewswire Inc.··Levi & Korsinsky, Llp

Class Action Lawsuit Filed Against REGENXBIO Over Gene Therapy Safety Disclosures

Law firm sues REGENXBIO for allegedly hiding safety concerns about gene therapy RGX-111. Stock dropped 17.8% after FDA clinical hold due to tumor in trial participant.
RGNXsecurities fraudclass action lawsuit