Faced with a legal deadline for a response, FDA denies without comment on the specifics a law firms petition seeking restrictions on approval of gener...
The CDRH 2025 annual report says the Center authorized 124 novel medical devices last year, one of the highest numbers of authorizations in history.
FDA places clinical holds on two Regenxbio investigational gene therapy programs for ultra-rare pediatric diseases following the identification of a c...
Boehringer Ingelheim says its investigational kidney drug apecotrep reduced proteinuria by 40% compared with placebo in a Phase 2 clinical trial invol...
An FDA Untitled Letter cautions ARS Pharmaceutical about false or misleading claims for its Neffy nasal spray.
Public Citizen asks a federal court to order the Trump administration to make public the terms of drug pricing deals it signed with Pfizer and Lilly.
An Akin legal update says FDAs recent issuance of Warning Letters to four direct-to-consumer testing companies over the use of unauthorized at-home bl...
FDA cites Nubratori Inc. for multiple manufacturing and contamination-control deficiencies following a December inspection of the companys Torrance, C...
