MarketPulse

Biologics License Application

21 articles
BenzingaBenzinga··Vandana Singh

Sanofi Pursues First On-Body Injector Cancer Drug as FDA Extends Review

Sanofi seeks FDA approval for first on-body injector cancer therapy; decision extended to July 2026. Tzield pediatric indication also expanded.
SNYFDA approvalBiologics License Application
GlobeNewswire Inc.GlobeNewswire Inc.··Bragar Eagel & Squire, P.C.

Inovio Faces Class Action Over Misleading Device Claims and Regulatory Setback

Class action lawsuit filed against Inovio Pharmaceuticals for allegedly making false statements about manufacturing deficiencies and overstating regulatory prospects, triggering 24.45% stock decline.
INOsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

UniQure Investors Face April 13 Deadline in FDA Approval Misrepresentation Lawsuit

Rosen Law Firm alerts $QURE investors with losses exceeding $100K to meet April 13 deadline in securities class action over alleged FDA approval status misrepresentation.
QUREINOinvestor lossessecurities class action
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.··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.··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
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Securities Class Action Filed Against uniQure Over FDA Approval Misrepresentations

Securities class action filed against uniQure alleging FDA approval misrepresentations. April 13, 2026 deadline for lead plaintiff claims.
QUREsecurities class actionFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Levi & Korsinsky, Llp

uniQure Faces Securities Lawsuit Over Alleged FDA Approval Misstatements

Levi & Korsinsky sued $QURE over false FDA statements. Investors who lost money Sept-Oct 2025 can claim damages by April 13, 2026.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

uniQure Faces Securities Lawsuit Over Huntington's Study Design Misrepresentation

uniQure faces securities lawsuit for allegedly misrepresenting Huntington's study design approval and downplaying BLA delays. Investors must act by April 13, 2026.
QUREsecurities class actionFDA approval
BenzingaBenzinga··Vandana Singh

J&J Wins FDA Nod for Multiple Myeloma Combo with Blockbuster 83% Survival Rate

FDA approves J&J's Tecvayli plus Darzalex Faspro for multiple myeloma with 83.3% three-year survival rate, expanding drug's label.
JNJPhase 3 clinical trialFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Holzer & Holzer, Llc

uniQure Securities Lawsuit: Investors Face April 2026 Deadline Amid FDA Approval Allegations

uniQure faces shareholder lawsuit alleging false statements on FDA approval and study design. Lead plaintiff deadline: April 13, 2026.
QUREshareholder lawsuitsecurities class action
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

uniQure Faces Securities Lawsuit Over Pivotal Study Misrepresentations

uniQure faces securities class action lawsuit alleging misstatements about Pivotal Study design and FDA approval. Lead plaintiff deadline: April 13, 2026.
LAKEQUREPSFEsecurities class actionlead plaintiff deadline
GlobeNewswire Inc.GlobeNewswire Inc.··Kahn Swick & Foti, Llc

uniQure Stock Crashes 49% After FDA Rejects Gene Therapy Data

uniQure stock plunges 49% after FDA rejects gene therapy data for AMT-130, triggering securities fraud class action lawsuit for investors trading September-October 2025.
QUREsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Levi & Korsinsky, Llp

Inovio Hit With Securities Lawsuit Over FDA Approval Claims

Levi & Korsinsky files class action against Inovio Pharmaceuticals alleging management misrepresented FDA accelerated approval eligibility for lead candidate, causing stock decline.
INOsecurities class actionBiologics License Application
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

uniQure Faces Securities Lawsuit Over FDA Study Design Misrepresentations

uniQure faces securities class action over alleged misrepresentations regarding FDA approval status of Huntington's Disease trial design and regulatory timeline delays. Lead plaintiff deadline April 13, 2026.
QUREsecurities class actionlead plaintiff deadline
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

UniQure Investors Urged to Consult Legal Counsel Ahead of Securities Suit Deadline

UniQure faces securities lawsuit alleging material misrepresentations about its Huntington's Disease trial design and FDA approval status. Lead plaintiff deadline is April 13, 2026.
QUREsecurities class actionFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Kirby Mcinerney Llp

Law Firm Launches Investigation into Alvotech Following FDA Facility Inspection Setback

Law firm investigates Alvotech after FDA rejected applications following failed facility inspection, causing stock to plunge 34%. Investors sought for potential securities litigation.
ALVOALVOWclass action lawsuitsecurities investigation
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
BenzingaBenzinga··Vandana Singh

FDA Accepts Moderna Flu Vaccine Application After Prior Rejection

FDA accepts Moderna's flu vaccine application after prior rejection, setting August priority review date. Stock surges 5.77% as company expands mRNA pipeline beyond COVID-19.
MRNAFBTXBIFDA approvalearnings beat
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

uniQure Investors Face April Deadline in Securities Litigation Over FDA Disclosure Claims

UniQure faces class action lawsuit over alleged FDA disclosure misrepresentations. Investors have until April 13, 2026 deadline to join litigation.
QUREsecurities fraudclass action lawsuit