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 ...
Medpage Today on MSN2d
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 ...
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 ...
Hosted on MSN8d
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) ...
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 ...
BioSpace4d
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, ...
Morningstar3d
ImmunityBio Provides Regulatory Update on Anticipated FDA Submissions in 2025 Following Meeting with the Agency
BCG unresponsive non-muscle invasive bladder cancer (NMIBC) in the papillary indication: Anticipated supplemental biologics license application (BLA) submission in 2025 Alternative source of BCG ...
MarketWatch9d
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.
Morningstar9d
Diamyd Medical confirms key advances toward Accelerated Approval for Diamyd® following FDA Type C Meeting
STOCKHOLM, Jan. 10, 2025 /PRNewswire/ -- Diamyd Medical provides an update following the receipt of final meeting minutes from a positive Type C meeting with the U.S. Food and Drug Administration ...