The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...

Sarepta Therapeutics' Elevidys for DMD shows revenue potential, with market cap justified at $11.4bn and potential for >50% ...

'Mad Money' host Jim Cramer weighs in on stock including: Anavex Life Sciences, Sarepta Therapeutics, Viking Therapeutics, ...

Mad Money” host Jim Cramer rings the lightning round bell, which means he’s giving his answers to callers’ stock questions at ...

The 12-month price targets, analyzed by analysts, offer insights with an average target of $151.64, a high estimate of ...

The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.

The pharma began submitting its TAR-200 bladder cancer treatment to the FDA. Elsewhere, Sarepta and Madrigal reported strong ...

A trial team led by Latham’s Mike Morin and David Frazier and Finnegan’s William (Bill) Raich helped Sarepta Therapeutics ...

The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...

Another 109 people reported injuries after using the remote cardiac monitoring software, Modern Healthcare reported. Other pharmaceutical and tech news is on the FDA's drug approval system and a rapid ...

Mizuho Securities analyst Uy Ear has assigned their bullish stance on SRPT stock, giving a Buy rating yesterday.Stay Ahead of the ...

Leerink Partners analyst Joseph Schwartz has reiterated their bullish stance on SRPT stock, giving a Buy rating yesterday.Stay Ahead of the ...