FDA approval

322 articles
The Motley FoolThe Motley Fool··Brett Schafer

FDA Caution on Nicotine Pouches Sends Turning Point Brands Stock Plummeting 15.5%

$TPB stock plunged 15.5% as FDA hesitation on nicotine pouch approvals threatens Fre brand growth, which rose 266% YoY but now faces regulatory headwinds.
TPBFDA approvalTurning Point Brands
GlobeNewswire Inc.GlobeNewswire Inc.··Glancy Prongay Wolke & Rotter Llp

Inovio Faces Securities Fraud Lawsuit Over INO-3107 Misstatements; Deadline Looms

$INO faces securities fraud lawsuit alleging false statements about INO-3107 regulatory timeline and CELLECTRA device manufacturing. Stock fell 24.45% in December 2025 after FDA rejected accelerated review.
INOsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

Corcept Faces Class Action Over Relacorilant Claims as FDA Concerns Mount

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

CORT Hit With Securities Fraud Claims Over FDA Rejection of Key Drug Candidate

$CORT faces securities fraud lawsuit alleging false statements about relacorilant's FDA approval status. Investors from October 2024-December 2025 can join class action with Schall Law Firm.
CORTsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

uniQure Faces Securities Lawsuit Over Huntington's Drug Study Disclosures

Securities class action filed against $QURE for alleged misrepresentation regarding Pivotal Study design and FDA approval timeline for Huntington's disease treatment.
QUREsecurities class actionlead plaintiff deadline
GlobeNewswire Inc.GlobeNewswire Inc.··Bragar Eagel & Squire, P.C.

uniQure Faces Class Action Over FDA Study Delays; Investor Claims Deadline Looms

uniQure faces securities class action over alleged FDA disclosure failures; investors have until April 13, 2026, to join litigation seeking damages.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Inovio Shareholders Face April Deadline in $100K+ Loss Securities Suit

Inovio shareholders with $100K+ losses must meet April 7 deadline to join securities lawsuit alleging false statements about CELLECTRA device and INO-3107 FDA timeline.
INOinvestor lossessecurities class action
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Esperion Closes Corstasis Deal, Adding First Nasal Loop Diuretic to Heart Drug Arsenal

Esperion completes acquisition of Corstasis, adding Enbumyst, first FDA-approved nasal spray loop diuretic, to expand its cardiovascular product portfolio.
ESPRacquisitionFDA approval
BenzingaBenzinga··Na

Esperion Closes Corstasis Acquisition, Adds First Nasal Spray Loop Diuretic to CV Portfolio

Esperion closes Corstasis acquisition, gaining FDA-approved Enbumyst nasal spray loop diuretic for heart failure treatment, leveraging existing cardiovascular commercial infrastructure.
ESPRacquisitionFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Corcept Therapeutics Faces Securities Lawsuit Over Relacorilant Trial Data Claims

Corcept Therapeutics faces class action lawsuit alleging misrepresentation of relacorilant clinical trial data and FDA approval prospects. Investors from Oct 2024-Dec 2025 may seek compensation.
CORTsecurities class actionrelacorilant
BenzingaBenzinga··Soligenix, Inc.

Soligenix's HyBryte Outperforms Valchlor in Cutaneous Lymphoma Study

Soligenix's HyBryte demonstrated superior efficacy versus Valchlor in treating cutaneous T-cell lymphoma, with 60% versus 20% success rates at 12 weeks, backed by $2.6M FDA grant.
SNGXFDA approvalclinical trial
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Priovant Advances Rare Disease Pipeline with Fourth Brepocitinib Indication

Priovant initiates Phase 2b/3 trial for brepocitinib in lichen planopilaris, marking fourth indication; dermatomyositis FDA decision expected Q3 2026.
ROIVFDA approvalrare disease
The Motley FoolThe Motley Fool··Eric Volkman

Eli Lilly Surges on FDA Approval of Foundayo, Challenging Novo Nordisk's Weight-Loss Dominance

Eli Lilly stock surged 4% after FDA approval of Foundayo, its oral weight-loss pill priced at $149/month, competing with Novo Nordisk's Wegovy.
LLYNVOFDA approvalstock performance
The Motley FoolThe Motley Fool··Eric Volkman

FDA Safety Concerns Crush Turning Point Brands Stock 14% on Nicotine Pouch Risks

Turning Point Brands stock drops 14% after FDA scientists express safety concerns about nicotine pouches, threatening approval of key products.
TPBregulatory riskFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Delveinsight

SLE Drug Race Heats Up: 120+ Pharma Giants Develop 140+ Pipeline Therapies

Over 120 pharmaceutical companies are developing 140+ drugs for systemic lupus erythematosus, with major players like Roche and Novartis advancing promising new treatment mechanisms.
JNJABBVNVSRHHBYAZN+3FDA approvalclinical trials
GlobeNewswire Inc.GlobeNewswire Inc.··Kahn Swick & Foti, Llc

Ultragenyx Stock Plunges 42% After Setrusumab Phase 3 Failure; Class Action Deadline Nears

Ultragenyx faces securities fraud lawsuit after setrusumab Phase 3 failure triggered 42% stock decline. Lead plaintiff applications due April 6, 2026.
RAREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Kahn Swick & Foti, Llc

Corcept Plunges 50% After FDA Rejects Lead Drug; Securities Lawsuit Filed

Corcept Therapeutics faces securities class action after FDA rejected relacorilant, causing 50% stock collapse. Investors have until April 21 to file claims.
CORTsecurities fraudclass action lawsuit
BenzingaBenzinga··Usa News Group

$578B Regenerative Medicine Market Faces Manufacturing Crisis as Avaí Bio Pioneers Cell Banking Solution

Regenerative medicine market projected at $578B faces manufacturing bottleneck as Avaí Bio advances Master Cell Bank solution enabling scalable, off-the-shelf cell therapy production.
PRMEIOVAAVAIMDGLDNLIFDA approvalregenerative medicine
BenzingaBenzinga··Prnewswire

Galmed Files 2025 Annual Report as Aramchol Advances Through Clinical Pipeline

Galmed files 2025 annual report detailing Aramchol development for NASH and cardiometabolic diseases, including clinical trial progress and regulatory disclosures.
GLMDFDA approvalclinical trials
BenzingaBenzinga··Vandana Singh

Novo Nordisk Launches First Wegovy Subscription Plan to Cut Patient Costs

Novo Nordisk launches Wegovy subscription program with monthly pricing from $249-$329, offering up to $1,200 annual savings via telehealth partners.
NVOHIMSLFMDLFMDPFDA approvaltelehealth