FDA approval

322 articles
The Motley FoolThe Motley Fool··Andy Gould

Agios Insider Sells $82K in Stock, But RSU Vesting—Not Confidence—Tells Real Story

Agios insider Krishnan sells $82K in shares via routine RSU tax-withholding event. Retains 16,200 unvested RSUs and recent equity grants signal confidence amid PYRUKYND's 86% revenue growth.
XLVAGIOIHEFDA approvalbiotech
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Corcept Investors Face April Deadline in Securities Fraud Class Action Over Drug Trial Data

Rosen Law Firm files securities fraud class action against Corcept Therapeutics, alleging misrepresentation of relacorilant drug trial data. Lead plaintiff deadline: April 21, 2026.
CORTMNDYHCXYHTGCsecurities class actionrelacorilant
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Inovio Investors Face April 7 Deadline in Securities Fraud Case Over Device, Drug Claims

Rosen Law Firm urges Inovio Pharmaceuticals investors with losses exceeding $100K to file claims before April 7, 2026 deadline in ongoing securities class action lawsuit.
INOinvestor lossessecurities class action
GlobeNewswire Inc.GlobeNewswire Inc.··Glucotrack, Inc.

Glucotrack Narrows Losses, Advances Glucose Monitor Tech Toward FDA Trials

Glucotrack narrowed net losses to $19.4M in 2025 while advancing implantable glucose monitor toward FDA trials in H2 2026.
GCTKFDA approvalclinical trials
GlobeNewswire Inc.GlobeNewswire Inc.··Bridgebio Pharma, Inc.

BridgeBio's Acoramidis Cuts Mortality Risk in Half for Rare Heart Disease

BridgeBio reports acoramidis cuts all-cause mortality 44.7% and cardiovascular mortality 49.3% in ATTR-CM patients at Month 54 versus placebo.
BBIOFDA approvalclinical trial
BenzingaBenzinga··Vandana Singh

Biogen Stock Surges on FDA Nod for High-Dose Spinraza in Rare Muscle Disease

$BIOG rallies as FDA approves high-dose Spinraza for spinal muscular atrophy, while litifilimab shows positive Phase 2 lupus results.
BIIBFDA approvalbiotech
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

Inovio Faces Class Action Lawsuit Over Misleading Device Manufacturing Claims

Class action filed against $INO alleging executives made false statements about CELLECTRA device manufacturing and INO-3107 regulatory timeline between October 2023 and December 2025.
INOsecurities fraudclass action lawsuit
BenzingaBenzinga··Vandana Singh

United Therapeutics Surges 16.5% on Positive Lung Disease Trial Results

United Therapeutics stock surges 16.5% after TETON-1 Phase 3 study shows Tyvaso meets primary endpoint in lung fibrosis treatment, with priority FDA review expected by summer 2026.
UTHRFDA approvalclinical trial
GlobeNewswire Inc.GlobeNewswire Inc.··Teva Pharmaceutical Industries Ltd.

Teva Scales Biosimilars Pipeline with FDA Approval of PONLIMSI, Xolair Candidate Filing

Teva gains FDA approval for denosumab biosimilar PONLIMSI and achieves dual filing acceptance for omalizumab candidate, bolstering its biosimilars portfolio.
AMGNNVSTEVAFDA approvalbiopharmaceutical
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Teva Gains Biosimilar Momentum With FDA Approval, Dual Regulatory Filings

Teva wins FDA approval for PONLIMSI biosimilar and dual regulatory filing acceptance for omalizumab biosimilar, advancing its 'Pivot to Growth' strategy.
AMGNNVSTEVAFDA approvalregulatory filing
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Teva Advances Biosimilar Pipeline With FDA Approval of PONLIMSI and Xolair Candidate

Teva gains FDA approval for PONLIMSI denosumab biosimilar and dual regulatory acceptance for omalizumab candidate, advancing biosimilar growth strategy.
AMGNNVSTEVAFDA approvalpharmaceutical
BenzingaBenzinga··The Schall Law Firm

uniQure Hit With Securities Fraud Suit Over FDA Approval Claims

Schall Law Firm seeks lead plaintiffs in class action against $QURE for alleged false statements regarding FDA approval timeline and BLA submission misrepresentations.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Corcept Therapeutics Faces Securities Lawsuit Over Alleged Drug Trial Misrepresentations

Rosen Law Firm pursues class action against $CORT for allegedly misrepresenting relacorilant clinical trial data and FDA communications. Lead plaintiff deadline: April 21, 2026.
CORTENPHCIGLsecurities class actionrelacorilant
GlobeNewswire Inc.GlobeNewswire Inc.··Novartis

Novartis Fabhalta Shows 49% Slowing of Kidney Decline in Landmark IgAN Study

Novartis' Fabhalta slowed kidney function decline by 49.3% in Phase III trial, with FDA priority review granted for IgA nephropathy treatment.
NVSFDA approvalkidney disease
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

UniQure Faces Securities Class Action Over Huntington's Drug Study Design Disclosure

Rosen Law Firm urges $QURE investors to join securities lawsuit alleging misrepresentation of Pivotal Study design and BLA timeline delays. Lead plaintiff deadline: April 13, 2026.
QUREsecurities class actionFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Alumis' Psoriasis Drug Shows Strong Phase 3 Results, Paving Way for 2026 FDA Filing

Alumis reports positive Phase 3 results for envudeucitinib, achieving 68% PASI 90 skin clearance in plaque psoriasis patients, with FDA filing planned for late 2026.
ALMSquality of lifeTYK2 inhibitor
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Atara Biotherapeutics Hit With Securities Lawsuit Over Tabelecleucel Drug Claims

Rosen Law Firm sues Atara Biotherapeutics for allegedly misrepresenting tabelecleucel drug's regulatory prospects and manufacturing capabilities to investors between May 2024 and January 2026. Lead plaintiff deadline set for May 22, 2026.
ATRAsecurities class actionmisleading statements
The Motley FoolThe Motley Fool··Eric Volkman

Corcept Therapeutics Surges 9% on FDA Approval of Cancer Drug Lifyorli

Corcept Therapeutics stock surged 9% following FDA approval of cancer drug Lifyorli. An analyst upgraded the stock to hold amid concerns about existing Korlym franchise performance.
CORTFDA approvalbiotech
GlobeNewswire Inc.GlobeNewswire Inc.··Not Specified

Monopar Strengthens Balance Sheet With $92M Raise, Eyes 2026 Drug Submission

Monopar reports $13.7M net loss, $140.4M cash reserves funding operations through 2027. Company plans mid-2026 NDA submission for Wilson disease treatment ALXN1840.
MNPRfinancial resultsFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

Corcept Faces Class Action Over Relacorilant Trial Claims and FDA Disclosure Gaps

Lawsuit filed against Corcept Therapeutics alleging false statements about relacorilant drug trials and FDA communications, covering October 2024-December 2025 investor purchases.
CORTsecurities fraudclass action lawsuit