FDA Related News

Biologics

BioMarin Refiling BLA for Hemophilia A Gene Therapy

BioMarin Pharmaceutical says it will resubmit by the end of September its BLA for hemophilia A gene therapy Roctavian (valoctocogene roxaparvovec) gen...

Biologics

Califf Says No Panel Will Review Covid Boosters

FDA commissioner Robert Califf says there are no new questions on the recently submitted Covid-19 booster vaccines and the agency will not need an adv...

Human Drugs

Comments on Breakthrough Therapy Recission Draft

Three stakeholders comment on an FDA draft guidance on rescinding breakthrough therapy designations.

Human Drugs

Imbruvica Pediatric sNDA Approved by FDA

FDA approves a Pharmacyclics supplemental NDA for Imbruvica (ibrutinib) for certain pediatric patients over one year of age with chronic graft versus ...

Human Drugs

FDA Releases 3 Drug Safety-Related Label Changes

FDA publishes drug safety-related labeling changes for Gleevec and Rapamune.

House Committee on Trump's Covid Pressure on FDA

A House Select Subcommittee on the Coronavirus Crisis report details evidence of what it sees as inappropriate Trump administration pressure on FDA ov...

Federal Register

Info Collection on Humanitarian Use Devices

Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Devices; Humanitarian Use Devices (HUD) 21 CFR part 814...

Federal Register

Device Labeling Info Collection

Federal Register notice: FDA seeks comments on an information collection revision entitled Medical Device Labeling Regulations.

Human Drugs

Amazon Warning Letter Raises Questions: Attorneys

Two Mintz attorneys discuss questions raised by a recent FDA Warning Letter involving the Amazon.com fulfillment service that delivered unapproved dru...

Biologics

Pull IPOL Polio Vaccine Until Better Trial Held: ICAN

The Informed Consent Action Network says FDA should withdraw approval of the IPOL polio vaccine until adequate clinical trials demonstrate its safety.