Topic:

Regulatory

Latest Headlines

Latest Headlines

Geron shares rocket up after FDA takes the cuffs off its lead drug

After putting up evidence to show that the liver toxicity triggered by its lead drug can be reversed, the FDA has lifted the full hold placed on its lead--and only--cancer drug. And investors responded enthusiastically to the biotech's return to the clinic, boosting shares by 35% in premarket trading.

Boehringer gets NICE nod for Pradaxa for DVT/PE in U.K.

Boehringer Ingelheim has completed a trifecta of approvals for its blood thinner Pradaxa for deep vein thrombosis and pulmonary embolism. The U.K. cost watchdog NICE has now given it a thumbs up after the FDA and the European regulators did the same thing this year.

FDA pulls back the curtain on Sarepta's latest DMD delay

In an uncommon move, the FDA has publicly weighed in on an in-development drug, clarifying the status of Sarepta Therapeutics' closely watched Duchenne muscular dystrophy treatment eteplirsen in light of an earlier setback that tanked the biotech's shares.

Daiichi Sankyo's new a-fib drug heads toward FDA approval and a crowded market

A panel of FDA advisers voted in favor of approving Daiichi Sankyo's irregular heartbeat treatment edoxaban, heralding its ability to break up blood clots and improving the company's odds of finally launching the drug in the U.S.

Novavax nabs FDA fast-track tag as search for H7N9 vaccine continues

Right now, the U.S. government is in search of an H7N9 vaccine that can reach the market to help prevent against a potential pandemic. And a new FDA fast-track designation for Novavax's candidate might help it get there a little sooner.

Chinese government urges hospitals to buy local devices

Unfortunately for foreign devicemakers, import substitution appears to be one of the means by which China intends to achieve its goal of creating 10 med tech breadwinners worth 5 billion yuan ($820 million) apiece by 2020.

AstraZeneca wins another diabetes approval in a fast-crowding market

AstraZeneca won an FDA nod for a one-pill combination of its latest diabetes drug and the long-generic metformin, making it the second to market among a cadre of drugmakers developing similar cocktails.

Novo Nordisk walks back some U.S. optimism for its next-gen insulin

Novo Nordisk is sounding a more cautious tone on Tresiba, its once-rejected new insulin. After hinting at an accelerated trip back to the FDA for the long-acting diabetes treatment, the Danish drugmaker now says it could be another few years before the injection is ready for another shot at approval.

Pfizer beats out Novartis with FDA MenB nod

We have a winner. In a two-horse race to grab the first-ever U.S. approval for a meningitis B vaccine, Pfizer has emerged victorious, nabbing the FDA's blessing Wednesday.

Daiichi Sankyo gains some in-house FDA support for a-fib drug edoxaban

Daiichi Sankyo's campaign to win approval for its atrial fibrillation drug edoxaban gained some support from regulators at the FDA who were clearly won over by the efficacy data in the NDA. But the internal review of the drug also includes recommendations for limiting its use to patients with abnormal kidney function. And they include a few cautionary notes on the competing drugs that have already made it to the market.