News

InnovationRx: Sarepta Blinks In Showdown With FDA
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
Fierce Pharma6h
Roche halts Elevidys distribution in some countries, following Sarepta's lead in US
Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...
InvestorsHub on MSN6h
Precision BioSciences shares climb after FDA grants orphan drug status
Precision BioSciences (NASDAQ:DTIL) saw its stock rise 5% following the announcement that the U.S. Food and Drug ...
KFF Health News8h
Humana Plans Outpatient Prior Authorization Requirement Cuts
In line with its aim to provide decisions within one business day on at least 95% of prior authorizations by next year, Humana will cut a third of its prior authorization requirements. It will also ...
Roche pauses Sarepta gene therapy shipments outside the U.S.
Sarepta Therapeutics (SRPT) stock is back in focus as Roche (RHHBF) pauses global shipments of its Elevidys gene therapy ...
BioSpace9h
Following Sarepta’s Lead, Roche Suspends Elevidys Shipments to Some Ex-US Countries
Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and ...
BioSpace10h
Sarepta’s Wild Week, CDER’s New Leader, FDA Rejections, Manufacturing Billions
Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug ...
STAT12h
Roche halts some shipments of Sarepta’s Duchenne gene therapy outside U.S.
Roche is following its partner Sarepta and halting shipments of the Duchenne gene therapy Elevidys in some countries, amid ...
Roche pauses shipments of Elevidys gene therapy outside US
Roche Holding AG said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside ...
Roche Pauses Contested Gene Therapy’s Shipments Outside US
Roche Holding AG paused some shipments of the controversial gene therapy Elevidys following a similar action by the embattled ...
Devdiscourse22h
Roche Pauses Global Shipments of Elevidys Gene Therapy
Roche Holding AG temporarily halted shipments of its muscular disorder gene therapy, Elevidys, outside the U.S., mirroring its U.S. partner Sarepta Therapeutics. The pause affects orders relying on ...