A 'Blue Bloods' Star Is Joining Donnie Wahlberg for His New Spin-Off The Fantastic Four: First Steps is no disaster – but ...

George Tidmarsh appointed to lead FDA drug review division amid staffing cuts and scrutiny over accelerated approvals and ...

Johnson & Johnson JNJ announced that it has submitted a new drug application (NDA) to the FDA seeking approval for its ...

With certain drug shortages persisting across the U.S., pharmacy leaders are adopting more coordinated strategies to manage supply disruptions. These include expanding on-hand inventory for critical ...

Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced ...

Study harnesses a cell-type-specific, multi-target drug discovery strategy grounded in human data and real-world evidence.

Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration ...

A Food and Drug Administration (FDA) expert panel has reignited a debate over whether hormone therapy should be used to treat menopause. The 12-person panel encouraged the use of the treatment late ...

The Supreme Court’s recent unanimous decision on FDA’s drug-approval authority is utterly unremarkable.

An analysis from the Congressional Budget Office warns that cuts to the National Institutes of Health and FDA drug reviews could significantly reduce the number of new medications reaching the U.S.

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...

Participants in trials of BrainStorm Cell Therapeutics' NurOwn filed a Citizens’ Petition with the FDA earlier this month ...