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 ...
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 ...
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 ...
Hosted on MSN9d
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 ...
Becker's Hospital Review4d
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 ...
Yahoo Finance10d
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 ...
Morningstar4d
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 ...
MarketWatch10d
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.
Nasdaq9d
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 ...