Hosted on MSN15h
FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for Urticaria
Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their resubmitted supplemental biologics license ...
Medscape5h
FDA Considers New Dupilumab Data for Chronic Spontaneous Urticaria Indication
The US Food and Drug Administration (FDA) has accepted a resubmission of the supplemental Biologics License Application for ...
MyChesCo on MSN3h
INOVIO Reports Third-Quarter Financial Results and Updates on INO-3107 Progress
INOVIO (NASDAQ: INO) has released its financial results for the third quarter of 2024, alongside updates on significant ...
Cure Today2d
FDA Receives Application for Dato-DXd Treatment in EGFR-Mutated NSCLC
For patients with previously treated EGFR-mutated NSCLC, a new BLA has been submitted to the FDA seeking the accelerated ...
Omeros Shares Hit 52-Week High on Plan to Resubmit Narsoplimab Application
Shares of Omeros touched a 52-week high, a day after the company said it could resubmit its biologics license application for narsoplimab to the Food and Drug Administration. In Thursday afternoon ...
MM&M6d
AstraZeneca: New drug data, promising earnings and a $3.5B R&D investment
AstraZeneca’s earnings were boosted by its oncology, cardiovascular, respiratory and immunology (R&I), and rare disease ...
Managed Healthcare Executive4d
FDA Sets Date For Resubmitted Dupixent in Inflammatory Skin Disease
The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...
FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease
Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a ...
Business Insider14h
Promising Initial Data and Favorable Regulatory Pathway Support Buy Rating for RegenXBio’s RGX-202 in DMD Treatment
The primary endpoint of achieving microdystrophin expression of at least 10% was met by all participants in the current trial phase, suggesting a high probability of positive outcomes for the pivotal ...
LakeShore Biopharma Initiates Biologics License Application of PIKA Rabies Vaccine to the Drug Regulatory Authority of Pakistan
GAITHERSBURG, Md., Nov. 07, 2024 (GLOBE NEWSWIRE) -- (Nasdaq: LSB) (“LakeShore Biopharma” or the “Company”), a global leader ...
FDA Cellular, Tissue & Gene Therapies Advisory Committee holds virtual meeting
The Committee discusses and makes recommendations for AstraZeneca (AZN) supplemental Biologics License Application (sBLA) 125586/546 for ...
The Bakersfield Californian12d
LakeShore Biopharma Initiates Biologics License Application of PIKA Rabies Vaccine to the Drug ...
LakeShore Biopharma Co., Ltd (Nasdaq: LSB) (“LakeShore Biopharma” or the “Company”), a global leader in the discovery, development, manufacturing, and delivery of ...