GLP-1 drugs, which include Ozempic and Wegovy, have become one of the most closely watched experimental approaches for ...
The U.S. Food and Drug Administration has approved Axogen's nerve repair graft, the health regulator said on Wednesday, ...
The US Food and Drug Administration’s new vaccine approval philosophy upends established regulatory practices and could put ...
In the New England Journal of Medicine, the former leaders wrote they were “deeply concerned” at how the top vaccine regulator is raising the bar for approvals.
While Imvax’s autologous immunotherapy IGV-001 missed the primary endpoint of progression-free survival in a Phase IIb trial, ...
A decade after being spun out of Thomas Jefferson University, Imvax is seeing promising results from its work to develop a ...
We're getting a lot of interest lately," this company's CEO said after a deal that saved the company's Covid vaccine push.
Moderna has continued to underperform the Nasdaq Composite over the past year, and analysts remain cautious about the stock’s ...
Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by ...
The FDA’s top vaccine regulator outlines proposed changes to the vaccine evaluation process in an internal memo.
A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...
Shares of several major vaccine makers lost ground Monday following a report U.S. vaccine approval rules could become ...
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