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

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 | 625 days ago

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 | 693 days ago

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

Genetic medicine maker Sarepta Therapeutics, Inc. (SRPT) announced Thursday that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the accelerated approval of SRP-9001 (delandistrogene moxeparvovec) to treat ambulant patients with Duchenne muscular dystrophy.

RTTNews | 960 days ago

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 | 983 days ago

U.S. Consumer Sentiment Unexpectedly Continues To Deteriorate In May

Consumer sentiment in the U.S. has unexpectedly continued to deteriorate in the month of May, according to preliminary data released by the University of Michigan on Friday. The University of Michigan said its consumer sentiment index dipped to 50.8 in May after slumping to 52.2 in April. Economists had expected the index to inch up to 53.4.

RTTNews | 1h 2min ago

U.S. Import, Export Prices Unexpectedly Inch Higher In April

The Labor Department released a report on Friday unexpectedly showing modest increases by both U.S. import and export prices in the month of April. The report said import prices crept up by 0.1 percent in April after falling by a downwardly revised 0.4 percent in March.

RTTNews | 1h 5min ago

U.S. Housing Starts Rebound Less Than Expected In April, Building Permits Pull Back Sharply

While the Commerce Department released a report on Friday showing a rebound by new residential construction in the U.S. in the month of April, the report also showed a substantial pullback by building permits during the month.

RTTNews | 1h 9min ago

Eurozone Trade Surplus Surges On Exports To US

The euro area trade surplus grew strongly in March as exports to the U.S increased sharply ahead of the expected increase in trade tariffs. The trade balance showed a surplus of EUR 36.8 billion compared to a EUR 22.8 billion surplus in the same period last year, Eurostat reported Friday.

RTTNews | 1h 55min ago

EURUSD	1.11446	GBPUSD	1.32595	AUDUSD	0.63897
USDJPY	145.991	USDCAD	1.39887	USDCHF	0.83981

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