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Amidst contentious debates, what path will the FDA take with accelerated approvals? Krebs Qin
May 06, 2024
Accelerated approval is a privilege that every applicant desires.
The Narrative of Pharmaceuticals Bestowed with Endorsement and Later Reclaimed by Oblivion by the FDA zhulikou431
March 06, 2024
This document endeavors to compile and elucidate data pertaining to instances where the U.S. FDA, in recent years, has rescinded market approval for pharmaceuticals previously sanctioned.
Johnson & Johnson’s Balversa therapy finally gets full FDA approval Shem Oirere
March 05, 2024
The approval by the Federal Drug Agency of the bladder cancer therapy Balversa has taken a notch higher the search for more treatment options.
Brief Summary of FDA Quality Management Maturity Program Muhammad Asim Niazi
March 05, 2024
United States FDA has a pivotal role in providing guidance for pharmaceutical quality attributes and defining new ways to improve the quality by publishing new regulations for quality enhancement.
Case study of FDA warning letters Muhammad Asim Niazi
January 23, 2024
A warning letter is a part of communication by the FDA with the manufacturer to share their finding to remove the discrepancy found during their inspection and inform the status of the manufacturer's measures.
New regulations in the Year 2023 for different regulatory bodies around the world Muhammad Asim Niazi
January 23, 2024
This article will explore new regulations in countries like the United States, Europe, Japan, and Australia.
How is the progress of China’s domestically produced PD-(L)1 “going global”? Yefenghong/PharmaSources
November 23, 2023
Recently, Coherus BioSciences announced that the FDA has approved the launch of PD-1 antibody toripalimab (marketed jointly by Junshi Biosciences and Coherus) for use in combination with gemcitabine/cisplatin as a first-line treatment for advanced recurre
Drug Marketing in China and Worldwide (June) Caicai/PharmaSources
July 12, 2023
Drug Marketing in China and Worldwide (June)
Drug Marketing in China and Worldwide (May) Caicai/PharmaSources
July 12, 2023
Drug Marketing in China and Worldwide (May)
Astellas’ non-hormonal VMS therapy gets FDA approval SHEM OIRERE
June 08, 2023
U.S. Food and Drug Administration has approved Veozah, the first neurokinin 3 receptor antagonist, to treat moderate to severe vasomotor symptoms.

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