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 ...
As Novo Nordisk cuts 400 jobs at the troubled site, Scholar Rock has seen enough progress that it included the facility in a ...
Another bidder, which remains unidentified, dropped out of the bidding process. Analysts at William Blair now think it ...
In addition to delivering two approved medicines to Biogen’s portfolio, the acquisition of Apellis Pharmaceuticals will ...
The license, which Innovent’s Altruist business said is the first of its kind, positions the CDMO to support commercial ...
Serial biotech investor Kevin Tang previously unsuccessfully tried to buy Kezar Life Sciences via Concentra Biosciences, a ...
Anthropic in October last year iterated its Claude AI model to better cater to biopharma purposes. Sanofi, Novo Nordisk, ...
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