FDA Related News

Biologics

CBER Updates 2024 Guidance Agenda

CBER publishes an updated 2024 guidance agenda with 20 listings.

Human Drugs

Elevar Resubmitting Cancer Drug NDA

Elevar Therapeutics says that after a meeting with FDA it is ready to resubmit its NDA for rivoceranib in combination with camrelizumab as a first-lin...

Human Drugs

Obsidian Gets Fast Track for OBX-115

FDA grants Obsidian Therapeutics a fast track designation for OBX-115, a T cell immunotherapy in combination with a pharmacologically regulatable memb...

Human Drugs

Checkpoint Resubmits Cosibelimab BLA

Checkpoint Therapeutics says it has completed the resubmission of a BLA for its cosibelimab cancer treatment.

Human Drugs

FDA OKs Pyzchiva as Stelara Biosimilar

FDA approves Samsung Bioepis Pyzchiva as an interchangeable biosimilar for Janssens Stelara.

Human Drugs

FDA OKs Genentechs Vabysmo Syringe

FDA approves a Genentech Vabysmo prefilled syringe to treat three retinal disorders with the same medicine as Vabysmo vials.

Human Drugs

FDA Drops Interchangeability Switching Studies

Venable attorney Robert Schwartz says an updated FDA guidance with alternatives to switching studies for demonstrating biosimilar interchangeability i...

Human Drugs

CGMP Violations in Sun Pharmaceutical Inspection

FDA warns Indias Sun Pharmaceutical Industries about repeat CGMP violations at one drug manufacturing facility and in other company facilities.

Opportunities, Risks in SCOTUS End to Chevron Deference: Lawyers

Attorneys in several law firms analyze the opportunities and risks for FDA-regulated companies arising from the Supreme Court decision to overturn Che...

Web Site Illegally Selling Semaglutide Products: FDA

FDA warns the ozempen.com Web site to stop offering unapproved and misbranded drugs to U.S. consumers.