RFK Jr. Wants to Close a Controversial FDA Loophole in Food Additive Regulation
The FDA’s GRAS rule lets companies decide if food additives are safe—without agency oversight. RFK Jr. now aims to close this ...
C&EN2d
Kennedy orders FDA to review food ingredient loophole
US Health and Human Services secretary Robert F. Kennedy Jr. directs the Food and Drug Administration to explore revamping ...
JD Supra12d
FDA Drug Review Threatened by a Government Shutdown
The Food and Drug Administration (FDA) is not likely to continue to review and approve human drugs or medical devices if the federal government shuts down in March The federal government is ...
Makary tells Senate panel he plans to review FDA job cuts
FDA nominee Martin Makary was asked about abortion drugs, vaccine panels during a Senate hearing on his bid to lead the ...
Kennedy asks FDA to revise 'self-affirm' rule for food ingredient safety
U.S. Secretary of Health and Human Services Robert Kennedy Jr. directed the Food and Drug Administration on Monday to revise ...
Hosted on MSN14d
Zevra sells priority review voucher for $150m to support drug launches
Zevra has sold its US Food and Drug Administration (FDA) priority review voucher (PRV ... sale to support the commercial launches of Miplyffa and the company’s urea cycle disorder drug Olpruva, which ...
Cytokinetics says FDA does not plan advisory committee meeting for aficamten NDA
In a regulatory filing, Cytokinetics (CYTK) disclosed that at upcoming investor conferences, the company will be providing, and is hereby ...
Fierce Pharma8d
In confirmation hearing, FDA nominee Martin Makary talks drug reviews, vaccines, ethics and more
After the contentious Senate confirmation of Robert F. Kennedy Jr., another crucial governmental health leadership ...
Oncology Nursing News7d
FDA Reviews Resubmitted BLA for Odronextamab in R/R Follicular Lymphoma
The FDA has accepted the resubmission of a BLA for odronextamab for the treatment of patients with relapsed/refractory ...