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 Supra2d
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 MSN3d
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 ...
FiercePharma3d
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 Dive4d
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 ...
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FDA Updates EXEL on Previously Scheduled ODAC Meeting for Cabozantinib
Exelixis, Inc. EXEL announced that the FDA has notified it about an update to its supplemental new drug application (sNDA) ...
Novo shares high-dose Wegovy results; Amgen, AstraZeneca drugs get expanded OKs
A high-dose form of Novo’s obesity drug led to 20% weight loss over 72 weeks. Meanwhile, Atara got a complete response letter ...
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 ...
Managed Healthcare Executive9d
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, ...
Healio11d
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 ...
Biohaven announces 2025 anticipated milestones
IgG MoDE Degraders: BHV-1300 Phase 1 completing last remaining dose cohorts with the optimized subcutaneous formulation with expected completion in 1H 2025. BHV-1310 first-in-human study anticipated ...
KTSA6d
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 ...