FDA

Black Friday for Spectrum as FDA lung cancer rejection prompts 75% cut to R&D workforce
Fierce Biotech
Mon, 11/28/22 - 10:40 am
Spectrum Pharmaceuticals
layoffs
R&D
FDA
Pozenveo
FDA lifts partial clinical suspension on Diamyd’s diabetes therapy trial
Clinical Trials Arena
Mon, 11/28/22 - 10:35 am
Diamyd Medical
clinical trials
FDA
type 1 diabetes
Diamyd
FDA pushes back Gamida Cell’s PDUFA date by three months
Endpoints
Sun, 11/27/22 - 07:12 pm
Gamida Cell
PDUFA
FDA
omidubicel
2 years after rejection, Mesoblast touts long-term cell therapy survival data as key to FDA resubmission
Fierce Biotech
Sun, 11/27/22 - 07:05 pm
Mesoblast
FDA
cell therapy
remestemcel-L
graft vs host disease
FDA grants priority review to Takeda’s BLA for dengue vaccine candidate
Pharmaceutical Business Review
Sat, 11/26/22 - 07:18 pm
Takeda
FDA
TAK-003
vaccines
dengue
FDA preps for DMD drug generics as Sarepta has yet to finish its confirmatory trial
Endpoints
Sat, 11/26/22 - 07:15 pm
Sarepta Therapeutics
generics
Duchenne Muscular Dystrophy
FDA
eteplirsen
uniQure, CSL claim first okay for hemophilia B gene therapy
Pharmaphorum
Wed, 11/23/22 - 07:53 am
uniQure
CSL
hemophila B
gene therapy
Hemgenix
FDA
Jazz plays coda to blood cancer approval, securing FDA nod for revised dosing schedule
Fierce Pharma
Tue, 11/22/22 - 04:41 pm
Jazz Pharmaceuticals
FDA
Rylaze
blood cancer
acute lymphoblastic leukemia
lymphoblastic lymphoma
Argenx Scores Priority Review for Generalized Myasthenia Gravis Therapeutic
BioSpace
Tue, 11/22/22 - 04:30 pm
Argenx
FDA
priority reviews
myasthenia gravis
efgartigimod
FDA extends deadline to decide on Gamida Cell's stem cell transplant therapy by three months
Fierce Biotech
Tue, 11/22/22 - 04:27 pm
Gamida Cell
FDA
stem cells
stem cell transplant
FDA approves Legend Biotech’s IND application for lung cancer therapy trial
Clinical Trials Arena
Tue, 11/22/22 - 10:58 am
FDA
Legend Biotech
LB2102
small cell lung cancer
Conservative group sues FDA in bid to overturn decades-old approval for abortion pill
Fierce Pharma
Mon, 11/21/22 - 07:13 pm
FDA
Mifeprex
abortion pill
legal
AbbVie's Roche-rivaling blood cancer bispecific gets FDA priority review, triggering Genmab payday
Fierce Biotech
Mon, 11/21/22 - 10:12 am
AbbVie
Genmab
FDA
Roche
epcoritamab
bispecific antibodies
relapsed or refractory large B-cell lymphoma
FDA Action Alert: Spectrum, ImmunoGen, Scynexis and Y-mAbs
BioSpace
Mon, 11/21/22 - 10:06 am
FDA
Spectrum Pharmaceuticals
poziotinib
Immunogen
mirevtuximab soravtansine
Scynexis
Brexafemme
Y-mAbs
Omblastys
This Week at FDA: Califf and Pazdur on return to office, accelerated approval, and more
RAPS.org
Sun, 11/20/22 - 12:46 pm
FDA
Robert Califf
Richard Pazdur
accelerated approvals
Project Pragmatica
FDA official discusses benefits, challenges of remote inspections
RAPS.org
Sun, 11/20/22 - 12:38 pm
regulatory
FDA
remote inspections
regulatory inspections
Philips’ ventilator woes grow as FDA issues alert over replacement foam
Medtech Dive
Sun, 11/20/22 - 12:34 pm
Philips
ventilators
Medtech
devices
FDA
Respironics Trilogy
FDA wants confirmatory trials to be underway before granting accelerated cancer nods, Pazdur says
RAPS.org
Fri, 11/18/22 - 10:32 am
FDA
cancer
oncology
accelerated approvals
Richard Pazdur
Iovance's BLA for Advanced Melanoma Therapeutic Delayed Until Q1 2023
BioSpace
Fri, 11/18/22 - 10:25 am
Iovance
FDA
lifileucel
metastatic melanoma
FDA greenlights Provention Bio's diabetes drug
Yahoo/Reuters
Fri, 11/18/22 - 10:22 am
Provention Bio
type 1 diabetes
FDA
teplizumab

Pages