FDA approval

Latest Headlines

Latest Headlines

UPDATED: FDA pins approval on Seattle Genetics' cancer drug Adcetris

Seattle Genetics ($SGEN) has crossed the finish line. The FDA has granted the biotech an accelerated approval for Adcetris to treat Hodgkin's lymphoma and anaplastic large cell lymphoma. While it's

Roche melanoma drug wins early FDA nod

The FDA came through with an early approval for Roche's new melanoma drug Zelboraf and the diagnostic test that targets it. The drug works on patients with a BRAF mutation, which amounts to about

Roche wins early approval for blockbuster melanoma drug vemurafenib

In a rare move, the FDA has stamped an early approval on Roche's remarkable new melanoma drug, vemurafenib, giving it a green light on a potential new blockbuster two months ahead of its PDUFA date.

FDA green lights combo HIV drug from J&J, Gilead

Collaborators at Johnson & Johnson and Gilead have won FDA approval of a new combo treatment for HIV expected to earn more than a half billion dollars a year. The agency announced yesterday

Merck, Novartis top drug-approval rankings

Studying the numbers on new-drug launches is a bit like parsing sports statistics. Some athletes are consistent-if-not-inspiring performers; others have hot streaks that run cold. Others take a

Now that Brilinta's approved, AZ has to sell it

After a knock-down at FDA on Tuesday, AstraZeneca ($AZN) got a leg up yesterday with the approval of its blood thinner Brilinta. It's been a long road, and the FDA nod isn't without its caveats.

UPDATED: AstraZeneca wins FDA approval for blockbuster hopeful Brilinta

The FDA has approved AstraZeneca's ($AZN) blood thinner Brilinta (ticagrelor) for acute coronary syndromes, breaking the Big Pharma company's long losing streak at the agency and pushing the

Woodcock: New drug approvals reach 20-year high

Is it too soon for the FDA to call 2011 a good year for drug approvals? Maybe not. CDER director Janet Woodcock claims that new chemical and molecular entity approvals have reached a 20-year high,

J&J gets FDA green light for blockbuster blood thinner Xarelto

J&J has scored another big regulatory win, gaining FDA approval late on Friday for Xarelto, a blood clot prevention therapy that has been tapped as one of the drug company's top six new drugs for

Novartis wins FDA OK of low-dose COPD therapy

Two years after the FDA originally stiff-armed Novartis on indacaterol inhalation powder regulators finally gave the COPD treatment a green light at a low dose. Word of the approval spread late on