Regulatory
The FDA granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) for IPD and pneumococcal pneumonia Breakthrough Therapy Designation.
Protagonist disclosed the FDA issued a letter of intent to rescind the status for rusfertide based on concerns first raised in a clinical hold placed on the drug.
Myovant said that the FDA provided notice it had found deficiencies that will preclude any potential discussion of labeling or post-marketing requirements at this time.
As Aeglea presents the data this week at the Society for Inherited Metabolic Disorders (SIMD), its stock has responded to both announcements with a strong leap.
Following the decision to limit the coverage of Biogen’s controversial Alzheimer’s drug Aduhelm, the Alzheimer’s community is now waiting for other companies to deliver new therapies.
Janssen Pharmaceutical, under parent organization Johnson & Johnson, secured an arbitrary win this week that results in royalty decisions stemming from licensing and marketing of daratumumab.
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.
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.
After wrapping up March with a flurry of PDUFA dates, the U.S. Food and Drug Administration has a more leisurely calendar for the first three weeks of April, at least in terms of drug approvals.
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