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).

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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.

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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.

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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 | Před 973 dny

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 | Před 37 minutami

U.S. Trade Deficit Spikes To Record High In March As Import Surge

The U.S. trade deficit spiked by much more than expected in the month of March, according to a report released by the Commerce Department on Tuesday. The report said the trade deficit soared to a record high $140.5 billion in March from a revised $123.2 billion in February.

RTTNews | Před 1 h 23 min

Eurozone Private Sector Growth Eases On Weaker Demand

Euro area private sector growth weakened in April as soft demand conditions limited the speed of expansion and weighed on sentiment, final results of the purchasing managers' survey by S&P Global showed on Tuesday. The HCOB final composite output index fell to 50.4 in April from 50.9 in March, but the reading suggested growth for the fourth straight month.

RTTNews | Před 2 h 27 min

U.S. Trade Deficit Surges Much More Than Expected In March

The U.S. trade deficit spiked by much more than expected in the month of March, according to a report released by the Commerce Department on Tuesday.

RTTNews | Před 2 h 51 min

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