FDA Related News

Human Drugs

Telix sNDA Approved for Illuccix Selection

FDA approves a Telix Pharmaceuticals supplemental NDA for Illuccix and its use in selecting prostate cancer patients for whom Novartis Pluvicto is ind...

Medical Devices

FDA Clears BD Vaginitis Test

FDA clears the BD Vaginal Panel running on the BD COR System to detect the three most common causes of vaginitis.

Biologics

Glaxo MenABCWY Vaccine Hits 11 Endpoints

GlaxoSmithKline says its meningococcal MenABCWY vaccine candidate met all 11 primary endpoints in a pivotal Phase 3 trial.

Biologics

IPRP Cell/Gene Therapy Raw Materials Paper

FDA publishes an International Pharmaceutical Regulators Program reflection paper addressing general considerations for using raw materials in the man...

FDA General

Senate Appropriators Announce 4/19 FDA Budget Hearing

The Senate Appropriations Committee announces a 4/19 subcommittee hearing to review FDAs fiscal year 2024 budget request.

Human Drugs

Panel Votes to Support Paxlovid NDA Approval

An FDA Advisory Committee votes 16 to 1 that Pfizers Paxlovid (nirmatrelvir and ritonavir) has a favorable benefit-risk profile for treating mild-to-m...

Human Drugs

Community Should Push AA Drug Studies: Califf

FDA commissioner Robert Califf calls on health insurers to play a role in seeing that confirmatory trials are completed for drugs approved through the...

Clinical Investigation Electronic Systems Guidance

FDA publishes a draft guidance on using electronic systems, records, and signatures in clinical investigations of some regulated products.

Human Drugs

FDA Modifies Partial Hold on Davet Syndrome Drug

FDA modifies a partial clinical hold against Stoke Therapeutics to allow the administration of a higher single dose of STK-001 (70 mg) in its ongoing ...

Human Drugs

Bill to Streamline Generic Drug Approvals

Sens. Paul and Hassan reintroduce their bill to require FDA to more clearly identify differences between generic drugs that have been submitted for ap...