Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...
ophthalmologytimes11h
Alvotech and Teva Pharmaceuticals announce FDA accepts Biologics License Application for AVT06
Alvotech and Teva Pharmaceuticals announced the US Food and Drug Administration (FDA) has accepted for review a Biologics ...
Managed Healthcare Executive15h
FDA Accepts Alvotech/Teva’s Application for Eylea Biosimilar
So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval ...
FDA To Review Teva and Alvotech Drug That Could Compete With Regeneron's Eylea
Teva Pharmaceutical Industries and partner Alvotech said the Food and Drug Administration agreed to review their AVTO6 ...
Opinion
FDA foot-dragging might have saved your hands, and you never knew it
The Trump administration is tearing down both regulations and the federal government that enforces them. The consequences will be enormous.
PMGC submits pre-IND meeting request to FDA for EL-22 in obesity
Northstrive Biosciences has submitted a pre-Investigational New Drug, or pre-IND, meeting request to the FDA for EL-22, a novel myostatin asset ...
Teva and Alvotech get FDA review acceptance for its proposed biosimilar to Eylea
Alvotech and Teva Pharmaceuticals said on Tuesday that the U.S. FDA has accepted for review a Biologics License Application ...
medtechdive13h
Medtronic nears FDA submission for Hugo robot
CEO Geoff Martha said Medtronic would submit its application for urological procedures to the Food and Drug Administration by ...
Ultragenyx’s BLA for UX111 accepted by FDA for priority review
Ultragenyx (RARE) announced the FDA has accepted for review the Biologics License Application, or BLA, seeking accelerated approval for UX111 ...
Contract Pharma16h
FDA Accepts Alvotech’s Eylea Biosimilar for Review
The U.S. Food and Drug Administration (FDA) has approved for review a Biologics License Application (BLA) for AVT06, Alvotech ...
How heavy metals get into baby food—and what California is doing to help parents
As of Jan. 1, 2025, every company that sells baby food products in California is required to test for four heavy metals every ...
Contract Pharma18h
sBLA for Dupixent Accepted by FDA for Priority Review
The US Food and Drug Administration (FDA) has accepted for priority review Sanofi’s supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid ...