A Louisiana court on April 7 asked the FDA to complete its internal review of mifepristone’s safety and gave the agency six ...
GSK discontinued Wellcovorin in 1999, but the FDA in September last year asked the pharma to refile an application, pointing ...
Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has ...
The FDA in its complete response letter to Replimune maintained its original objection to the single-arm trial the biotech ...
Last June, the FDA signaled how far that integration has progressed when it announced the use of Elsa, a generative AI tool, to support aspects of the drug approval process. While regulatory adoption ...
Another bidder, which remains unidentified, dropped out of the bidding process. Analysts at William Blair now think it ...
The license, which Innovent’s Altruist business said is the first of its kind, positions the CDMO to support commercial ...
Sidewinder Therapeutics’ bispecific antibody-drug conjugates target pairs of receptors found on cancer cells, which the ...
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 ...
BioSpace’s Biopharma Job Market Report reveals early signs of recovery for 2026. A rise in job postings, a surge in contract ...
Gilead Sciences has inked three deals this year so far totaling $14.77 billion, a marked escalation of the company’s usual ...
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