FDA approval

170 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Nicox Sa

Nicox's NCX 470 Achieves Primary Efficacy Endpoints in Phase 3 Glaucoma Trial

Nicox's NCX 470 eye drop met primary efficacy endpoints in Phase 3 glaucoma trials, showing superior IOP reduction versus standard treatment with favorable safety profile.
BLCOPhase 3 clinical trialFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Palvella to Present Phase 3 QTORIN Trial Results for Lymphatic Malformations

Palvella to present Phase 3 SELVA trial results for QTORIN gel treating lymphatic malformations on February 24, 2026, with data release at 6:30 a.m. ET.
PVLAPhase 3 clinical trialFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Beam Therapeutics to Unveil 2025 Results and Novel Liver Disease Program

Beam Therapeutics will discuss 2025 results and unveil a new liver disease program on February 24, 2026. The company also secured FDA alignment for accelerated approval of BEAM-302.
BEAMFDA approvalbase editing
GlobeNewswire Inc.GlobeNewswire Inc.··Delveinsight

Neuromodulation Device Market to Double by 2032 Amid Rising Neurological Disease Burden

Neuromodulation device market expected to double to $16.1 billion by 2032, driven by rising neurological diseases, technological advances, and regulatory support.
MDTBSXABTLIVNFDA approvalmarket growth
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

uniQure Faces Class Action Over FDA Study Claims and BLA Timeline Disclosures

uniQure faces class action lawsuit alleging misleading statements about FDA study status and BLA timeline delays. Investors who purchased shares Sept-Oct 2025 may be eligible to claim.
QUREsecurities fraudclass action lawsuit
Investing.comInvesting.com··Timothy Fries

Gilead to Acquire Arcellx for $7.8B, Expanding CAR-T Therapy Portfolio

Gilead acquires Arcellx for $7.8B to expand CAR-T therapy portfolio, strengthening oncology pipeline and cell therapy capabilities.
GILDACLXacquisitionFDA approval
The Motley FoolThe Motley Fool··Jonathan Ponciano

Commodore Capital Cuts Nuvalent Position by $84M Despite Strong Stock Performance

Commodore Capital cuts $84M Nuvalent stake to 3.68% despite 29% stock gains. Biotech firm awaits September PDUFA decision for lead drug candidate.
RLAYNUVLFDA approvalclinical trials
BenzingaBenzinga··Vandana Singh

Teva Advances Monthly Schizophrenia Injection Toward FDA Approval

Teva's once-monthly schizophrenia injection TEV-749 advances toward FDA approval, aiming to improve patient medication compliance and reduce healthcare burden compared to daily oral treatments.
TEVAFDA approvalschizophrenia treatment
BenzingaBenzinga··Vandana Singh

Gilead to Acquire Arcellx for $7.8B to Expand CAR-T Oncology Portfolio

Gilead acquires Arcellx for $7.8B to gain CAR-T therapy anito-cel for multiple myeloma, with FDA approval expected by late 2026.
GILDACLXacquisitionFDA approval
The Motley FoolThe Motley Fool··Prosper Junior Bakiny

Inovio Pharmaceuticals Faces Regulatory Headwinds Amid Capital Constraints

Inovio Pharmaceuticals faces FDA rejection of its lead drug candidate and mounting cash constraints, raising questions about the biotech firm's long-term viability without revenue-generating products.
INOFDA approvalbiotech
BenzingaBenzinga··Vandana Singh

Novo Nordisk Shares Decline on CagriSema Trial Setback Versus Lilly Rival

Novo Nordisk shares plunged 13% after CagriSema obesity drug trial missed non-inferiority target versus Eli Lilly's tirzepatide, threatening competitive positioning.
LLYNVOFDA approvalclinical trial
The Motley FoolThe Motley Fool··Jonathan Ponciano

Perceptive Advisors Doubles Down on Praxis, Stock Rallies 320%

Perceptive Advisors doubles investment in Praxis Precision Medicines to $588M, now largest holding. Stock surges 320% amid FDA submissions and strong cash position.
PRAXFDA approvalinstitutional investment
The Motley FoolThe Motley Fool··Jonathan Ponciano

Perceptive Advisors Doubles Down on Celcuity as Stock Ascends 700% YoY

Perceptive Advisors doubled its Celcuity stake to 5.62% of AUM, making it the fund's second-largest holding. Stock surged 700% YoY ahead of expected FDA approval for lead drug Gedatolisib.
CELCFDA approvalbiotech
The Motley FoolThe Motley Fool··Eric Volkman

Medtronic's Defensive Profile and Dividend Consistency Offer Market Stability

Medtronic offers defensive stability through 48 years of dividend increases, essential medical devices, and consistent profitability across economic cycles.
MDThealthcareFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Inovio Pharmaceuticals Faces Securities Class Action Over Device, Regulatory Claims

Inovio Pharmaceuticals faces securities lawsuit alleging false statements about its CELLECTRA device and regulatory prospects. Investors who purchased stock between October 2023-December 2025 may qualify for compensation.
INOsecurities class actionlead plaintiff deadline
BenzingaBenzinga··Nabaparna Bhattacharya

Large-Cap Stocks Rally on Earnings Beat and Corporate Actions

Large-cap stocks rallied on strong earnings and corporate actions. First Majestic Silver led with 25% gains, joined by Moderna and Global Payments on positive results.
COINPAASFIGAGMRNA+6earningsFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Class Action Deadline Looms for uniQure Investors Amid FDA Approval Claims

uniQure faces securities class action over allegedly misleading FDA approval claims and timeline delays. Investors must act before April 13, 2026 deadline.
QUREVTGNLUinvestor lossessecurities class action
GlobeNewswire Inc.GlobeNewswire Inc.··The Schall Law Firm

Class Action Lawsuit Filed Against uniQure Over Alleged Regulatory Misstatements

Securities fraud lawsuit filed against uniQure for allegedly making false statements about FDA approval processes and BLA submission timelines, causing investor losses.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Not Specified

FDA Accepts Teva's Application for Monthly Olanzapine Injection to Treat Schizophrenia

FDA accepts Teva's application for monthly olanzapine injection treating schizophrenia. The formulation eliminates post-injection monitoring requirements while maintaining efficacy.
TEVAFDA approvalschizophrenia treatment
The Motley FoolThe Motley Fool··Prosper Junior Bakiny

CRISPR Therapeutics Advances Gene-Editing Platform With First Approved Therapy

CRISPR Therapeutics gains FDA approval for Casgevy, its first gene-editing therapy for rare blood disorders, validating the platform with multiple pipeline candidates in development.
CRSPFDA approvalclinical trials