sarepta
FDA U-turns to approve Sarepta’s Vyondys 53 in Duchenne muscular dystrophy
December 13, 2019Medical Communications, Sales and Marketing FDA, Vyondys 53, pharma, sarepta
The FDA has surprised industry pundits by choosing to approve Sarepta’s Vyondys 53 under an accelerated pathway for the treatment …
Sarepta’s investigational gene therapy shows strength in limb-girdle muscular dystrophy Type 2E
October 7, 2019Research and Development, Sales and Marketing muscular dystrophy, pharma, sarepta
Sarepta Therapeutics has revealed positive new data for its investigational gene therapy SRP-9003 in the treatment of limb-girdle muscular dystrophy …
FDA turns down Sarepta’s DMD drug over safety concerns
August 20, 2019Manufacturing and Production DMD, FDA, approval safety, pharma, sarepta
The FDA has declined to approve Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) drug, citing safety concerns including risk of infection …
Sarepta’s Exondys 51 hit with negative CHMP opinion in Duchenne muscular dystrophy
September 24, 2018Research and Development, Sales and Marketing CHMP, Duchenne Muscular Dystophy, EMA, Europe, Exondys 51, pharma, sarepta
Sarepta Therapeutics has been rocked by a hurdle in its pursuit of regulatory approval in Europe, as the company revealed …
Sarepta shares surge after gene therapy leads to microdystrophin expression in DMD patients
June 20, 2018Research and Development Duchenne Muscular Dystrophy, pharma, sarepta
This week, shares in Sarepta Therapeutics rocketed by 80% after the company released preliminary data from a Phase 1/2a trial …
Duchenne drug gets FDA approval in “unprecedented” ruling
September 20, 2016Manufacturing and Production, Sales and Marketing Duchenne Muscular Dystrophy, FDA, sarepta
The FDA has gone against the advice of its own staff to approve the first treatment of Duchenne muscular dystrophy …
Weekly Movers: Lion Biotech, Adamis, Sarepta…
June 13, 2016Manufacturing and Production, Research and Development, Sales and Marketing Alexion, Biogen, Shares, Stock Markets, Stock Movement, drug trial, sarepta
Drug trial results remained the important theme over the past week with several companies announcing key study results. The trial …
New FDA expanded access guidelines spell trouble for Sarepta
June 2, 2016Medical Communications, Research and Development, Sales and Marketing Duchenne Muscular Dystrophy, Eteplirsen, FDA, compassionate grounds, sarepta
New guidelines intended to streamline the process of expanded access to medicines by the US Food and Drug Administration (FDA) …
Shares at Sarepta Therapeutics jump after FDA delay in drug approval review
May 26, 2016Research and Development, Sales and Marketing Duchenne Muscular Dystrophy, FDA, Sarepta Therapeutics, approval, delay, delayed announcement, muscular dystrophy, sarepta, treatment
Sarepta Therapeutics (NASDAQ: SRPT) has witnessed a sharp rise in the price of its shares after the US Food and …
US panel says Sarepta’s trial DMD drug not proven effective
April 26, 2016Manufacturing and Production, Research and Development DMD, US FDA, drug trial, sarepta
A US advisory committee has concluded Sarepta Therapeutics’ (Nasdaq: SRPT) trial drug to treat muscle wasting condition has not proved …
Shares plunge at Sarepta after negative FDA review on muscle disorder drug
April 21, 2016Research and Development, Sales and Marketing FDA, Sarepta Therapeutics, Shares, dive, fall, negative, plunge, sarepta
Sarepta Therapeutics (NASDAQ: SPRT) is counting the cost as shares plunge following a negative review given by staff at the …
