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 Supra3d
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 ...
Medpage Today on MSN4d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...
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 Dive5d
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) ...
FierceBiotech3d
Lykos still plotting path to approval for rejected MDMA therapy after 'productive' FDA meeting
In a post-market statement on Jan. 16, Lykos gave a fresh update following what it described as a “productive” meeting with the FDA on Wednesday. “We continue to chart a path forward for an ...
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 ...
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 ...
Exelixis Notified by FDA That Cabozantinib Application Won't Be Discussed at Meeting
Exelixis said it was notified by the Food and Drug Administration that its treatment for advanced pancreatic neuroendocrine tumors and advanced extra-pancreatic will not be discussed at a meeting.
BioSpace5d
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, ...
Nasdaq10d
FDA Updates EXEL on Previously Scheduled ODAC Meeting for Cabozantinib
The FDA has now notified the company that its sNDA will no longer be the subject of discussion at the ODAC meeting. The sNDA is under FDA review and has a target action date of April 3 ...