Sarepta Therapeutics Says FDA Lifts Clinical Hold On SRP-5051 To Treat 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 | Pred 716 dňami

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 | Pred 784 dňami

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 | Pred 814 dňami

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 | Pred 1051 dňami

U.S. Consumer Sentiment Unexpectedly Deteriorates In August

Consumer sentiment in the U.S. has unexpectedly deteriorated in the month of August, according to preliminary data released by the University of Michigan on Friday. The University of Michigan said its consumer sentiment index fell to 58.6 in August from 61.7 in July. Economists had expected the index to inch up to 62.0.

RTTNews | Pred 12 minútami

U.S. Industrial Production Pulls Back Slightly In July

A report released by the Federal Reserve on Friday showed a modest decrease by U.S. industrial production in the month of July. The Fed said industrial production edged down by 0.1 percent in July after climbing by an upwardly revised 0.4 percent in June. Economists had expected industrial production to come in unchanged.

RTTNews | Pred 41 minútami

New York Manufacturing Index Unexpectedly Climbs To Nine-Month High In August

The Federal Reserve Bank of New York released a report on Friday showing regional manufacturing activity unexpectedly grew at a faster rate in the month of August. The New York Fed said its general business conditions index climbed to 11.9 in August from 5.5 in July, with a positive reading indicating growth. Economists had expected the index to fall to 0.5.

RTTNews | Pred 1 h 6 min

U.S. Consumer Sentiment Index Unexpectedly Decreases In August

Consumer sentiment in the U.S. has unexpectedly deteriorated in the month of August, according to preliminary data released by the University of Michigan on Friday.

RTTNews | Pred 1 h 32 min

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