Red dye No. 3 is now banned in the US. Here’s what studies show about more common dyes
Following the ban of red dye No. 3 in the United States, experts weigh in on the potential health risks of red dye No. 40, ...
JD Supra1d
FDA announces public meeting on pediatric exclusivity and drug development
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of ...
Hosted on MSN2d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
The FDA needs to strengthen guardrails to ensure its accelerated approval pathway is used appropriately, the HHS Office of ...
FiercePharma2d
Government watchdog recommends tweaks to FDA accelerated approval program
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
BioPharma Dive3d
Federal watchdog cites concerns with FDA’s accelerated approval process
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
New York Post1mon
FDA says knockoff versions of weight loss drug must come off the market
They use the same active ingredient, tirzepatide. The FDA said Thursday that “Lilly’s supply is currently meeting or exceeding demand,” after two years of shortages. Both drugs are part of ...
No FDA advisory meeting for Exelixis a positive, says Citi
Citi keeps a Buy rating on Exelixis (EXEL) with a $38 price target after the company announced that it has been notified by the FDA that the ...
Becker's Hospital Review3d
Watchdog flags flaws in FDA's fast-track drug approvals
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...
Healio10d
FDA says RSV vaccines must come with Guillain-Barré warning
The FDA is adding a warning about Guillain-Barré syndrome to the respiratory syncytial virus vaccines manufactured by GSK and ...
Managed Healthcare Executive8d
FDA to Hold Ad Comm Meeting for Rexulti in PTSD
The target action date for Rexulti in combination with sertraline to treat patients with post-traumatic stress disorder, ...
KTSA5d
What is Red 40 and why hasn’t the FDA banned the dye?
Lefferts was closely involved with a push by the Center for Science in the Public Interest for the FDA to curb use of ...
BioSpace3d
Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...