The FDA rejected AstraZeneca's subcutaneous Saphnelo application, delaying U.S. approval until 2026, despite positive ...

The US Food and Drug Administration (FDA) issued a complete response letter (CRL) regarding the Biologics License Application ...

AstraZeneca has hit what appears to be a minor speed bump in gaining clearance in the U.S. for its subcutaneous (SC) version ...

Monash University researchers, alongside key partner Halozyme Therapeutics, report findings in support of shifting the way ...

Merck posted a modest 2026 outlook that fell short of estimates, as it prepares for some drugs to go off patent later this ...

The FDA has issued a complete response letter to AstraZeneca regarding its application for subcutaneous administration of ...

Merck forecasts $65.5--$67 billion in 2026 sales, excluding China Gardasil shipments, despite stronger results from newer medicines.

Feb 3 (Reuters) - AstraZeneca said on Tuesday that the U.S. health regulator had rejected its application for an ...

February 2026 Update on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus The US Food and Drug Administration (FDA) issued a complete response letter (CRL) ...

Novo Nordisk NVO announced positive top-line data from a late-stage study in its global REIMAGINE clinical study program for ...

The company is working with the U.S. regulator to move forward with an updated application, adding a decision is expected in ...

Feb 3 (Reuters) - AstraZeneca said on Tuesday the U.S. health regulator has rejected its application for a self-injectable ...