Regulatory
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.
In a meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, six members voted not to approve the NDA for Amylyx’s ALS candidate, AMX0035, while four voted in favor.
Although it looks that we’re on the downside of the COVID-19 pandemic in the U.S., biopharma companies are still working on developing better treatments and preventions.
Antares Pharma has announced that the U.S. Food and Drug Administration has granted approval to its therapeutic Tlando intended for testosterone replacement therapy (TRT).
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