FDA Related News

Whistleblower Report Details FDA Hydroxychloroquine Role

A whistleblower report by ousted Biomedical Advanced Research and Development Authority director Rick Bright details the roles of senior FDA officials...

Federal Register

FDA Nixes Devices Referencing Drugs New Uses

Federal Register notice: FDA announces that it is abandoning a 9/2017-published approach that would have enabled device sponsors to obtain marketing a...

Human Drugs

Cytomegalovirus Treatment Guidance

FDA issues a guidance to aid development and clinical trial designs for drugs to treat cytomegalovirus in specified post-transplant populations.

Human Drugs

Farxiga Gets Expanded Approval in Heart Failure

FDA approves AstraZenecas Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of card...

Medical Devices

Eased FDA Enforcement Not Likely Permanent: Attorneys

Two Mintz attorneys say FDAs relaxed enforcement on medical devices during the Covid-19 public health emergency is not likely to continue completely b...

Human Drugs

Cabaletta Wins Fast Track for CAAR T-cell

FDA grants Cabaletta Bio fast track status for DSG3-CAART (Desmoglein 3 Chimeric Auto-Antibody Receptor T cells) for treating mucosal pemphigus vulgar...

Human Drugs

FDA Extends Review of BMS CAR T-cell Therapy

FDA extends by three months its review of a Bristol Myers Squibb BLA for lisocabtagene maraleucel for treating adults with relapsed or refractory larg...

Human Drugs

FDA Approves Novartis Lung Cancer Drug

FDA approves a Novartis Pharmaceuticals NDA for Tabrecta (capmatinib) for treating certain adult patients with non-small cell lung cancer.

Medical Devices

HeadsafeIPs Brain Assessment Device Cleared

FDA clears a HeadsafeIP 510(k) for its Nurochek system for brain assessment in patients aged 14 years and older.

Human Drugs

Praise, Suggestions for Enhanced Purple Book

Two drug industry associations praise FDA for improving the Purple Book and suggest further enhancements.