The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used ...
GSK discontinued Wellcovorin in 1999, but the FDA in September last year asked the pharma to refile an application, pointing ...
As a drug moves through research and regulatory processes, any mistakes in the data will be compounded. Small gaps that a ...
A Louisiana court on April 7 asked the FDA to complete its internal review of mifepristone’s safety and gave the agency six ...
Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has ...
Sidewinder Therapeutics’ bispecific antibody-drug conjugates target pairs of receptors found on cancer cells, which the ...
The license, which Innovent’s Altruist business said is the first of its kind, positions the CDMO to support commercial ...
Another bidder, which remains unidentified, dropped out of the bidding process. Analysts at William Blair now think it ...
Industry leader Steve Ubl has served as PhRMA’s CEO for more than a decade, the longest tenure of any head of the trade group ...
In this episode of Denatured, you'll hear from Jason Jones, head of global business development at Cellular Origins and ...
As Novo Nordisk cuts 400 jobs at the troubled site, Scholar Rock has seen enough progress that it included the facility in a ...
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