Por: RTTNews Health November 27, 2023
Biopharmaceutical company Outlook Therapeutics, Inc. () announced Monday the receipt of the official minutes from the Type A meeting with the U.S. Food and Drug Administration (FDA) held in October 2023.The type A meeting was regarding the Complete Response Letter (CRL) dated August 29, 2023 for the Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.As... + full article
RTTNews USA Health November 27, 2023
Abeona Therapeutics Inc. () announced the FDA has accepted and granted Priority Review for the Biologics License Application for pz-cel, the company's investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic... + más
Bluebird Bio Says FDA Accepts BLA For Lovotibeglogene Autotemcel For Priority Review | RTTNews
Somerville-based Bluebird Bio expects delay on FDA sickle cell drug application | The Boston Globe
RTTNews USA Health September 18, 2023
Orchard Therapeutics (), a global gene therapy leader, announced Monday that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for OTL-200 in metachromatic leukodystrophy (MLD) under Priority Review.The BLA for OTL-200... + más
Protalix Resubmits To FDA The BLA For Pegunigalsidase Alfa For Treatment Of Fabry Disease | RTTNews
High school scores and top performers from Friday, March 24 | Orlando Sentinel
ESPN USA Sports September 06, 2023
The NIL contract that rookie signed with a speculative investment capital company while playing at the University of Florida in 2022 violated a state NIL law in place at the time, the Florida state legislator who sponsored the bill told ESPN on Tuesday.Dexter, a second-round... + más
'Dexter' prequel confirmed: Everything to know about 'Origins' and more | Newsweek
Every NBA finals matchup and winner | ESPN
RTTNews USA Health June 21, 2023
bluebird bio, Inc. () announced Wednesday that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) for priority review. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of... + más
Bluebird Lake Placid Debuts In The Adirondacks | Forbes
Why Bluebird Backcountry Is The Most Unique Ski Resort In The U.S. | Forbes
RTTNews USA Health May 24, 2023
Sarepta Therapeutics, Inc. () 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... + más
FDA advisers recommend accelerated approval of a Sarepta gene therapy | The Boston Globe
Sarepta Submits BLA For SRP-9001 To Treat Ambulant Patients With Duchenne Muscular Dystrophy | RTTNews
RTTNews USA Health November 14, 2022
Biopharmaceutical company Protalix BioTherapeutics, Inc. () announced Monday the resubmission on Wednesday of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for PRX-102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry... + más
Valtteri Bottas Is Thriving In Leadership Role With Alfa Romeo | Forbes
RTTNews USA Health September 29, 2022
Genetic medicine maker Sarepta Therapeutics, Inc. () 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... + más
Diageo Debuts Its 2022 Special Releases Collection | Forbes
Parents of son diagnosed with Duchenne muscular dystrophy are hopeful cure will be found soon | ABC7
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