The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and ...
Gilead pharmaceutical company announced today (Tuesday, Feb. 18) that the U.S. Food and Drug Administration has accepted the ...
PharmaTher Holdings (CSE:PHRM) is on track to resubmit information to the U.S. Food and Drug Administration (FDA) by the end ...
The Breakthrough Therapy Designation process is intended to expedite ... including the New Drug Applications seeking FDA approval and the MAA and EU-M4all seeking EMA approval of lenacapavir ...
Manufacturers are typically obligated to conduct confirmatory post-approval clinical trials to verify these clinical benefits. A new policy ... that of all 278 drug applications granted ...
Equecabtagene Autoleucel (trade name: FUCASO) was approved by China's National ... "We are delighted that the New Drug Application for Equecabtagene Autoleucel has been officially accepted ...
For the first time in two decades, the Food and Drug Administration (FDA) has approved a new class of medication that provides an alternative to addictive opioids for patients looking to manage ...
Federal officials on Thursday approved a new type of pain drug designed to eliminate the ... s modest effectiveness and lengthy development process underscore the challenges of finding new ways ...
February 18, 2025--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions fo ...