Pharmafile Logo
Pharmafocus logo
Advanced Search

sarepta

Showing 11 posts of 11 posts found.

FDA U-turns to approve Sarepta’s Vyondys 53 in Duchenne muscular dystrophy

December 13, 2019
Medical 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 …

News
7359dba7-e1da-4eb4-8765-58da6178899b

Sarepta’s investigational gene therapy shows strength in limb-girdle muscular dystrophy Type 2E

October 7, 2019
Research 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 …

News
5204602349_c87b204860_z

FDA turns down Sarepta’s DMD drug over safety concerns

August 20, 2019
Manufacturing 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 …

News
7359dba7-e1da-4eb4-8765-58da6178899b

Sarepta’s Exondys 51 hit with negative CHMP opinion in Duchenne muscular dystrophy

September 24, 2018
Research 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 …

News
shutterstock_159488225

Sarepta shares surge after gene therapy leads to microdystrophin expression in DMD patients

June 20, 2018
Research 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 …

News

Duchenne drug gets FDA approval in “unprecedented” ruling

September 20, 2016
Manufacturing 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 …

News
stocks1

Weekly Movers: Lion Biotech, Adamis, Sarepta…

June 13, 2016
Manufacturing 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 …

Feature

New FDA expanded access guidelines spell trouble for Sarepta

June 2, 2016
Medical 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) …

News
lab

Shares at Sarepta Therapeutics jump after FDA delay in drug approval review

May 26, 2016
Research 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 …

News
clinicaltrial1

US panel says Sarepta’s trial DMD drug not proven effective

April 26, 2016
Manufacturing 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 …

News
figures_charts

Shares plunge at Sarepta after negative FDA review on muscle disorder drug

April 21, 2016
Research 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 …

News

Latest content

Eli Lilly acquires new manufacturing facility from Nexus Pharmaceuticals

April 24, 2024

GSK’s Jemperli accepted for FDA review for endometrial cancer treatment

April 24, 2024

Sanofi shares results for phase 3 LUNA 3 trial in immune thrombocytopenia

April 23, 2024

FDA approves ImmunityBio’s Anktiva bladder cancer treatment

April 23, 2024

EC approves Pfizer’s Emblaveo for multidrug-resistant infection treatment

April 22, 2024