FDA Related News

Human Drugs

Group Criticizes FDA Foot Dragging on Phenylephrine

Advocacy group Public Citizen criticizes FDA for dragging its feet in removing phenylephrine from the U.S. market.

Human Drugs

Dizal NDA for Lung Cancer Drug

Dizal Pharmaceutical submits an NDA for sunvozertinib for treating locally advanced or metastatic non-small cell lung cancer.

Human Drugs

Neurotech Review Extension on Retinal Disease BLA

FDA extends its review of a Neurotech Pharmaceuticals BLA for NT-501 (revakinagene taroretcel) as a treatment for macular telangiectasia Type 2.

Biologics

Darxalex Faspro sBLA for Smoldering Multiple Myeloma

Johnson & Johnson files a supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) and its use for treating adult patients with high-...

Medical Devices

Bayers Medrad Centargo CT Injection Cleared

FDA clears a Bayer 510(k) for its Medrad Centargo CT Injection System, a multi-patient injector for use in computed tomography.

Human Drugs

Allogene Reports Encouraging CAR-T Therapy Data

Allogene Therapeutics reports encouraging response rate data for its investigational ALLO-316 in advanced renal cell carcinoma, but the results also s...

Human Drugs

Model-Informed Drug Development Comments

Four stakeholders respond to an FDA request for comments on guidance development and engaging with stakeholders on model-informed drug development.

Medical Devices

Electa Instrument Recalls Biopsy Needle Kits

Elekta Instrument AB recalls (Class 1) its Elekta Disposable Biopsy Needle Kit for the Leksell Stereotactic System due to microscopic debris found on ...

FDA General

How Soon Will Trump Nominate Next FDA Head?

FDA watchers need patience as they wait to see who president-elect Donald Trump chooses to nominate as the next FDA commissioner.

IRB Violations Seen in FDA-483s

FDA identifies four trends in IRB violations from FDA-483s issued in FY 2023.