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accelerated approval
FDA's Peter Marks backs accelerated approval for gene therapies
BioSpace
Tue, 03/21/23 - 11:36 am
FDA
CDER
Peter Marks
gene therapy
accelerated approval
Researchers call on FDA to get tough on accelerated approval labeling
RAPS.org
Mon, 03/6/23 - 11:19 pm
FDA
regulatory
accelerated approval
CMS Outlines 3 New Drug Pricing Models Targeting Wide Scope of Therapies
American Journal of Managed Care
Wed, 02/15/23 - 10:42 am
drug pricing
CMS
Medicare
Medicaid
accelerated approval
RegenXBio gets FDA support for Hunter syndrome gene therapy's accelerated review filing—in 2024
Fierce Biotech
Wed, 08/3/22 - 10:58 am
Regenxbio
Hunter Syndrome
RGX-121
accelerated approval
FDA
FDA’s accelerated approval program: Is change on the way?
RAPS.org
Mon, 10/11/21 - 09:53 pm
FDA
regulatory
accelerated approval
FDA hands accelerated nod to Seagen, Genmab's solo ADC in cervical cancer, but combo studies look even more promising
Endpoints
Mon, 09/20/21 - 11:01 pm
Seagen
Genmab
Tivdak
FDA
accelerated approval
cervical cancer
Roche to withdraw US accelerated approval for Tecentriq to treat breast cancer
Pharmaceutical Business Review
Mon, 08/30/21 - 10:42 am
Roche
Tecentriq
Abraxane
triple negative breast cancer
FDA
accelerated approval