Positive data from a pair of acute pain studies convinced the company that its drug, which works differently than existing medications, has a good shot at reaching market.

A new federal commission will ‘investigate’ decades-old mental health as well as weight loss drugs, prompting concerns from ...

The FDA is expected to decide on treatments for dry eye disease, neuroendocrine tumors, chronic spontaneous urticaria, Barth syndrome, and migraine.

Roche’s RHHBY member company, Genentech, announced the FDA approval of TNKase (tenecteplase), a thrombolytic or ...

New SEC filings from pharmaceutical companies reveal Donald Trump and Elon Musk’s cost-cutting measures could slow drug ...

Neffy 1 mg is the “first significant innovation” for epinephrine delivery in small children aged 4 years and up in over 35 ...

Mirum gained the drug, which it will sell as Ctexli for adults with cerebrotendinous xanthomatosis, in a 2023 deal with ...

The FDA has approved TNKase, a new, fast-acting stroke treatment that dissolves blood clots more efficiently, marking a significant advancement in stroke therapy and clot-busting technology.

The U.S. Food and Drug Administration has expanded its indication of ALK's Odactra, a house dust mite allergen tablet, for ...

Watching dogs grow and get older is a bittersweet experience, but what if there was a way we could give our canine companions ...

The Food and Drug Administration (FDA) has approved TNKase ® (tenecteplase) for the treatment of acute ischemic stroke (AIS) in adults. The approval was supported by data from th ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...