FDA approval

322 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

Corcept Faces Class Action Over Relacorilant Misstatements to Investors

Class action lawsuit filed against Corcept Therapeutics alleging executives made false statements about relacorilant's clinical strength and FDA approval prospects.
CORTsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··The Schall Law Firm

Atara Biotherapeutics Faces Securities Fraud Lawsuit Over Misleading Drug Trial Claims

Schall Law Firm launches class action against $ATRA for allegedly concealing manufacturing problems and overstating tabelecleucel prospects in ALLELE study.
ATRAsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··The Gross Law Firm

ATRA Faces Securities Class Action Over FDA Drug Approval Setbacks

Shareholders sue Atara Biotherapeutics for allegedly misleading statements on manufacturing issues and failed ALLELE study data affecting tabelecleucel approval prospects.
ATRAshareholder lawsuitsecurities class action
GlobeNewswire Inc.GlobeNewswire Inc.··Delveinsight

Lung Cancer Drug Race Heats Up: 100+ Companies Pursue NSCLC Breakthroughs

Over 100 pharmaceutical companies compete to develop 120+ NSCLC pipeline drugs, with 30+ in late-stage trials. Precision oncology advances drive innovation in biomarker-selected populations.
JNJMRKPFEABBVLLY+6FDA approvalclinical trials
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

Aquestive Therapeutics Hit by Securities Fraud Class Action Over FDA Approval Claims

Aquestive Therapeutics faces class action lawsuit alleging securities fraud over false FDA approval statements and concealed anaphylaxis product risks.
AQSTSLNOGOSSsecurities fraudclass action lawsuit
BenzingaBenzinga··Vandana Singh

Eli Lilly's Oral Weight Loss Drug Clears Cardiovascular Safety Hurdle

Eli Lilly's oral weight loss drug Foundayo met cardiovascular safety goals in Phase 3 trials, showing 57% lower mortality risk versus insulin. FDA filing planned for Q2 2026.
LLYFDA approvalweight-loss drug
BenzingaBenzinga··Globe Newswire

MeiraGTx Acquires Johnson & Johnson's Gene Therapy for Rare Blindness

MeiraGTx acquires J&J's bota-vec gene therapy for rare blindness in $25M deal, targeting 2027 launch with promising Phase 3 clinical data.
JNJMGTXFDA approvalclinical trial
GlobeNewswire Inc.GlobeNewswire Inc.··Immutep Limited

Immutep Wins FDA Orphan Drug Nod for Sarcoma Treatment Eftilagimod Alfa

Immutep gains FDA orphan drug designation for eftilagimod alfa in soft tissue sarcoma, with Phase II trial results exceeding efficacy targets by 47%.
MRKIMMPFDA approvalorphan drug designation
GlobeNewswire Inc.GlobeNewswire Inc.··Tonix Pharmaceuticals

Tonix's TONMYA Shows Strong Pharmacokinetics Data as First New Fibromyalgia Treatment in 15 Years Gains Traction

Tonix Pharmaceuticals publishes peer-reviewed pharmacokinetic data for TONMYA, the first new fibromyalgia treatment in 15 years, showing rapid absorption and superior bioavailability.
TNXPFDA approvalclinical trial
BenzingaBenzinga··Vandana Singh

Praxis Precision Surges on FDA Nod for Essential Tremor Treatment

Praxis Precision shares surge 7.15% after FDA accepts essential tremor drug application with January 2027 decision target and positive Phase 3 results.
PRAXFDA approvalbiotech
GlobeNewswire Inc.GlobeNewswire Inc.··The Schall Law Firm

Atara Biotherapeutics Faces Class Action Over Alleged Securities Fraud

Schall Law Firm recruits investors for class action against Atara Biotherapeutics over alleged securities fraud involving tabelecleucel drug and ALLELE study claims, covering May 2024-January 2026 purchases.
ATRAsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Not Specified

Amneal Enters Inhalation Market With Two Respiratory Product Launches

Amneal launches first two respiratory inhalers, targeting $1.8B combined market opportunity from dedicated Ireland facility.
AMRXFDA approvalmarket expansion
GlobeNewswire Inc.GlobeNewswire Inc.··Levi & Korsinsky, Llp

Corcept Therapeutics Faces Securities Fraud Lawsuit Over Misleading FDA Claims

Law firm Levi & Korsinsky filed class action suit against $CORT alleging fraud regarding relacorilant FDA approval prospects between October 2024 and December 2025.
CORTsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··The Schall Law Firm

uniQure Faces Class Action Fraud Suit Over FDA Approval Claims

Schall Law Firm initiates securities fraud class action against uniQure ($QURE) over alleged false FDA approval statements and misleading BLA timelines.
QUREsecurities fraudclass action lawsuit
BenzingaBenzinga··Vandana Singh

Telix Pharma Surges on $2.14B Regeneron Deal for Solid Tumor Radiotherapies

Telix Pharma secures $2.14B partnership with Regeneron for solid tumor radiopharmaceuticals while reporting 11% quarterly revenue growth and FDA acceptance of brain cancer imaging application.
TLXREGNFDA approvalsolid tumors
BenzingaBenzinga··Vandana Singh

IDEAYA's Eye Cancer Drug Combo Demolishes Standard Therapy in Pivotal Trial

$IDYA's darovasertib-crizotinib combination doubled progression-free survival in metastatic uveal melanoma versus standard care, with FDA submission planned for late 2026.
IDYAFDA approvalprogression-free survival
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Securities Lawsuit Targets Atara Biotherapeutics Over Tabelecleucel Disclosure Failures

Securities lawsuit alleges Atara Biotherapeutics concealed manufacturing issues and clinical study deficiencies for tabelecleucel. Investors with $100K+ losses must act before May 22, 2026 deadline.
ATRAinvestor lossessecurities class action
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

Corcept Therapeutics Faces Class Action Over Relacorilant Clinical Trial Claims

Class action filed against $CORP alleging securities fraud over misleading statements about relacorilant clinical trials and FDA regulatory prospects.
CORTsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Milestone Pharmaceuticals Inc.

Milestone Pharma Launches Real-World Evidence Registry for CARDAMYST Following FDA Approval

Milestone Pharmaceuticals launches RESET-PSVT real-world evidence registry for FDA-approved CARDAMYST nasal spray, enrolling 450 patients across 20 sites beginning end of 2026.
MISTFDA approvalreal-world evidence
GlobeNewswire Inc.GlobeNewswire Inc.··Telix Pharmaceuticals Limited

FDA Accepts Telix's Pixclara NDA for Glioma Imaging; Decision Due Sept. 2026

FDA accepts Telix's Pixclara NDA for glioma imaging with September 2026 decision target. Orphan Drug designation provides competitive advantages.
TLXFDA approvalradiopharmaceuticals