The U.S. Food and Drug Administration has approved Bravecto Quantum, a new shot that protects dogs six months or older ...

Merck MRK announced that the FDA has accepted for review the new drug application (“NDA”) seeking approval for its investigational, once-daily, oral, two-drug, single-tablet regimen of ...

Merck MRK announced a definitive agreement to acquire Verona Pharma VRNA for approximately $10 billion. The deal will add ...

The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with a caveat.

Fluralaner for extended-release injectable suspension (Bravecto Quantum) is also indicated for treatment of lone star tick in ...

If approved, doravirine/islatravir would be the first two-drug HIV treatment regimen without an integrase inhibitor, ...

The Food and Drug Administration (FDA) has accepted the New Drug Application for doravirine/islatravir (DOR/ISL) for adults with virologically-suppressed HIV-1 infection.

The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters related to medicines that were later approved, in a bid to improve transparency ...

Merck on Thursday said the application covers the investigational, once-daily, oral two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy. The ...

Verona Pharma brings to Merck the inhaled drug Ohtuvayre, which is FDA approved as a treatment for chronic obstructive pulmonary disease. While Ohtuvayre is projected to become a blockbuster product ...