MarketPulse

FDA approval

322 articles
GlobeNewswire Inc.GlobeNewswire Inc.··The Gross Law Firm

uniQure Faces Securities Lawsuit Over Alleged Misleading FDA Claims

The Gross Law Firm filed a class action lawsuit against uniQure N.V. for allegedly making false statements about FDA approval and BLA timeline prospects.
QUREshareholder lawsuitsecurities class action
BenzingaBenzinga··Vandana Singh

Novo Nordisk Scores Historic FDA Win With First Weekly Basal Insulin

Novo Nordisk wins FDA approval for Awiqli, the first once-weekly basal insulin for Type 2 diabetes, potentially improving patient adherence and capturing significant market share.
NVOFDA approvalclinical trial
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Humacyte Posts $2M Revenue as Biotech Pushes Toward FDA Approval Milestone

Biotech firm Humacyte reported $2M in 2025 revenues from 61 Symvess unit sales, secured Saudi Arabia commitment, and targets critical Phase 3 results in Q2 2026.
HUMAHUMAWPhase 3 clinical trialFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Autolus Therapeutics Plc

Autolus Therapeutics Posts $74.3M Revenue as AUCATZYL Scales Across Europe

Autolus Therapeutics reported $74.3M in 2025 AUCATZYL revenue with UK launch underway. Company projects $120-135M in 2026 revenue and positive gross margin expansion.
AUTLFDA approvalclinical trials
GlobeNewswire Inc.GlobeNewswire Inc.··Novo Nordisk A/S

Novo Nordisk's Awiqli Wins FDA Approval as First Once-Weekly Basal Insulin for Type 2 Diabetes

FDA approves Novo Nordisk's Awiqli, the first once-weekly basal insulin for type 2 diabetes, launching in US during second half 2026 based on successful ONWARDS trials.
NVOFDA approvalType 2 diabetes
The Motley FoolThe Motley Fool··Lee Samaha

Grail Stock Surges on Analyst Optimism Despite Cancer Test Setback

Grail stock jumped 11.4% as Wall Street analysts see upside in its cancer detection test despite February trial disappointment.
GRALFDA approvalcancer detection
BenzingaBenzinga··Vandana Singh

Ionis Slashes Tryngolza Price 93% Ahead of FDA Label Expansion Decision

Ionis Pharmaceuticals cuts Tryngolza price from $595K to $40K annually, positioning for broader FDA approval and potential $2B+ peak sales.
IONSFDA approvalmarket expansion
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

Atara Biotherapeutics Hit With Class Action Over Misleading FDA Study Claims

Class action lawsuit filed against $ATARAWITH alleging executives made false statements about manufacturing issues and ALLELE study deficiencies that could block FDA approval of tabelecleucel.
ATRAsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Portnoy Law Firm

Aquestive Therapeutics Hit by Class Action Over FDA Anaphylm Disclosure Failures

Portnoy Law Firm files class action against Aquestive Therapeutics for allegedly failing to disclose FDA deficiencies in Anaphylm NDA, causing 37% stock decline.
AQSTclass action lawsuitstock decline
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Kamada Secures FDA Approval for Major Texas Plasma Hub, Eyes $8-10M Revenue Stream

Kamada Ltd. gains FDA approval for its San Antonio plasma collection center, expected to generate $8-10 million annually at full capacity.
KMDAFDA approvalrevenue generation
GlobeNewswire Inc.GlobeNewswire Inc.··Claimsfiler

uniQure Stock Crashes 49% After FDA Rejection; Class Action Deadline Looms

uniQure faces securities lawsuit after FDA rejected AMT-130 drug candidate data adequacy. Stock plunged 49% following disclosure. Lead plaintiff deadline April 13, 2026.
QUREsecurities class actionlead plaintiff deadline
The Motley FoolThe Motley Fool··Prosper Junior Bakiny

Two Biotech Stocks Poised to Outpace Summit Therapeutics Amid FDA Uncertainty

Summit Therapeutics faces FDA decision on ivonescimab by November 2026 amid efficacy concerns, while Axsome and Madrigal positioned for outperformance.
AXSMMDGLSMMTregulatory riskFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Kahn Swick & Foti, Llc

Driven Brands Faces Securities Fraud Suit Over Misstated Financials, Stock Plummets 39%

Driven Brands Holdings faces securities fraud class action over undisclosed financial statement errors spanning 2023-2025, triggering a 39% stock decline.
QUREDRVNTCOMsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Kahn Swick & Foti, Llc

Corcept Therapeutics Faces Securities Fraud Suit Over Undisclosed FDA Setback

Class action lawsuit filed against Corcept Therapeutics alleging securities fraud tied to FDA rejection of relacorilant, triggering 50% stock plunge.
CORTQURETCOMsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Pomerantz Llp

Pomerantz Files Securities Fraud Suit Against $INO Over FDA Approval Misstatements

Pomerantz LLP sues Inovio Pharmaceuticals for alleged securities fraud over FDA approval misstatements. Stock fell 3.1% and 24.45% following manufacturing delays and accelerated approval rejection.
INOsecurities fraudclass action lawsuit
BenzingaBenzinga··Vandana Singh

Abivax Dismisses M&A Speculation, Plans Capital Raise Before Trial Readout

Abivax CEO dismisses acquisition rumors, plans equity and debt raise after Phase 3 obefazimod data in Q2 2026. $614.42M cash runway supports strategy.
LLYAZNABVXFDA approvalbiotech
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

Corcept Faces Class Action Over Relacorilant Claims as Investors Allege Misleading Trial Data

Class action lawsuit filed against $COPT alleging executives misrepresented relacorilant clinical trial strength and FDA approval prospects, harming investors.
CORTsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Corcept Faces Securities Lawsuit Over Relacorilant Clinical Data Misrepresentation

Rosen Law Firm notifies Corcept investors about securities lawsuit alleging misrepresentation of relacorilant clinical data and concealment of FDA concerns during October 2024-December 2025.
CORTsecurities class actionrelacorilant
GlobeNewswire Inc.GlobeNewswire Inc.··Levi & Korsinsky, Llp

Aquestive Faces Securities Fraud Suit Over Anaphylm FDA Misrepresentation

Aquestive Therapeutics faces securities fraud lawsuit after FDA rejected Anaphylm drug, contradicting management's prior "on track" statements; $AQST stock fell 37%.
AQSTsecurities fraudclass action lawsuit
BenzingaBenzinga··Soligenix, Inc.

Soligenix's HyBryte Shows Promise Against Cutaneous Lymphoma at 2026 Workshop

Soligenix's HyBryte™ cutaneous lymphoma therapy shows positive results ahead of 2026 presentation, with FDA awarding $2.6M development grant.
SNGXPhase 3 clinical trialFDA approval