Food and Drug Administration (FDA)
NEWS
The Accelerated Approval Integrity Act of 2022 (H.R. 6963) aims to remove loopholes in the FDA’s accelerated approval pathway. The bill, however, fails to adequately consider the whole picture.
The delay is related to a third-party secondary packaging and labeling facility that Alnylam planned to use for the launch of vutrisiran.
New data from Roche’s study on the use of Ocrevus to treat patients with primary and secondary progressive multiple sclerosis demonstrated positive outcomes.
Merck strengthened its HPV vaccines manufacturing capacity with the expansion of its facility in Elkton, Virginia. Also, an additional 150 new jobs are created.
Fabry disease treatment is going to get new updates as Protalix and Chiesi are seeking approval. This can be a game-changer in the market. Here’s more about it.
Kite Pharma, a subsidiary of Gilead, announced that its Yescarta® has been approved by the U.S. Food and Drug Administration (FDA).
Mavacamten is often referred to as “first-in-class” because it addresses the root cause of obstructions. Here’s everything you should know about its recent progress.
Neurocrine has noticed some positive results of valbenazine for treating Huntington’s diseases related chorea. Here’s all about what they found in the study.
The FDA requested additional data analyses from the pediatric studies that Merck stated it has submitted. The final decision is expected on July 1, 2022.
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