Sarepta Submits BLA For SRP-9001 To Treat Ambulant Patients With Duchenne Muscular Dystrophy

Quest Diagnostics Says FDA Grants Breakthrough Designation For Adeno-associated Virus Test

Quest Diagnostics (DGX), a diagnostic information services provider, announced Wednesday that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

RTTNews | 615天前

FDA OKs Elevidys As First Gene Therapy To Treat Duchenne Muscular Dystrophy

Sarepta Therapeutics, Inc. announced Friday that the U.S. Food and Drug Administration or FDA has accelerated approval of ELEVIDYS (delandistrogene moxeparvovec-rokl) for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.

RTTNews | 683天前

Sarepta Therapeutics Updates Of BLA For Sarepta's Duchenne Muscular Dystrophy Drug Candidate

Sarepta Therapeutics, Inc. (SRPT) on Wednesday provided the following update on the Biologics License Application (BLA) for SRP-9001 (delandistrogene moxeparvovec), which is currently under review for the treatment of ambulant individuals with Duchenne muscular dystrophy (DMD) who have a confirmed mutation of the DMD gene.

RTTNews | 713天前

Sarepta Therapeutics Says FDA Lifts Clinical Hold On SRP-5051 To Treat Duchenne Muscular Dystrophy

Genetic medicine maker Sarepta Therapeutics, Inc. (SRPT) announced Tuesday that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on SRP-5051 (vesleteplirsen), the Company's investigational, next-generation peptide-conjugated phosphorodiamidate morpholino oligomer (PPMO) to treat patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping.

RTTNews | 973天前

Canadian Stocks Marginally Down In Cautious Trade

Canadian stocks are turning in a mixed performance on Tuesday with investors largely refraining from making significant moves amid lingering concerns about tariffs and some weak earnings updates.

RTTNews | 2小时4分钟前

Swiss Market Ends Flat After Choppy Session

The Switzerland market closed slightly weak after a choppy ride on Tuesday as investors mostly stayed cautious, looking for fresh triggers. The Federal Reserve and the Bank of England are scheduled to announce their rate decisions on Wednesday and Thursday, respectively.

RTTNews | 2小时35分钟前

European Stocks Close Broadly Lower Ahead Of Key Policy Announcements

European stocks closed broadly lower on Tuesday with investors largely staying cautious, following political and geopolitical developments, digesting economic and earnings updates, and awaiting the monetary policy announcements from the Federal Reserve and the Bank of England, due later in the week.

RTTNews | 2小时51分钟前

UK Car Sales Drop 10.4% In April As Higher Taxes Hurt - SMMT

New car registrations in the U.K. decreased in April mainly due to customers making purchases early to avoid higher taxes that came into effect at the start of the month, though electric car sales continued to increase, monthly data from the Society of Motor Manufacturers and Traders showed on Tuesday.

RTTNews | 4小时49分钟前

EURUSD	1.1373	GBPUSD	1.33788	AUDUSD	0.64986
USDJPY	142.41	USDCAD	1.37685	USDCHF	0.82161

Advertisement

Sarepta Submits BLA For SRP-9001 To Treat Ambulant Patients With Duchenne Muscular Dystrophy