US FDA issued CRL to ViiV Healthcare for use of cabotegravir and rilpivirine long-acting regimen for treatment of HIV
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete... Read More
US FDA issues Complete Response Lette to Takeda’s Entyvio for maintenance therapy in adults with ulcerative colitis
Takeda Pharmaceutical Company Limited received a Complete Response Letter from the US Food and Drug Administration (FDA) in response to the submission... Read More
Insight on USFDA approval of Allergan’s Ubrelvy
Allergan plc announced that the US Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Ubrelvy (ubrogepant) for... Read More
What is USFDA Purple Book? What it’s significance?
Posted on19 Nov 2019
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The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act... Read More
USFDA approved Pfizer’s Abrilada, a biosimilar of Humira
Posted on19 Nov 2019
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The U.S. Food and Drug Administration (FDA) approved Pfizer’s Abrilada, a biosimilar of Humira. Pfizer said the FDA approved Abrilada (adalimumab-afzb) for the treatment of... Read More
Selumetinib NDA Submission for Neurofibromatosis Type 1 (NF1) granted Priority Review
AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration... Read More
Case Study: 505(b)(2) filing pathway – USFDA approval of Vumerity
Biogen, global biotechnology company, and Alkermes, global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) approved Vumerity (diroximel fumarate),... Read More
US FDA places partial hold on Novartis’ AVXS-101 intrathecal study
USFDA placed a partial hold on clinical trials for intrathecal administration of AVXS-101. The announcement follows an AveXis communication to health authorities... Read More
Insighht on USFDA approval of Trikafta
Vertex Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA). This is a landmark approval where Vertex’s Trikafta earned this... Read More
US FDA issued warning letter to Glenmark for Baddi plant
Posted on21 Oct 2019
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The US Food and Drug Administration has issued a warning letter to Glenmark Pharmaceutical Ltd’s manufacturing plant in Baddi, Himachal Pradesh, the company said... Read More