drug approvals

House committees kick off investigation into how Biogen's Aduhelm won approval
Endpoints
Tue, 07/13/21 - 10:48 am
US Congress
Biogen
Aduhelm
FDA
drug approvals
Alzheimer's disease
Calls grow for an investigation into FDA approval of Biogen’s Alzheimer’s drug
Stat
Wed, 06/30/21 - 10:20 pm
FDA
Biogen
Aduhelm
drug approvals
Patient experience data in regulatory decisions: Questions abound in first FDA report
Endpoints
Wed, 06/30/21 - 11:13 am
FDA
regulatory
patients
patient experience data
drug approvals
The big approvals still on the cards for 2021
EP Vantage
Thu, 06/17/21 - 11:00 am
FDA
drug approvals
Argenx
Novartis
AstraZeneca
Astellas
UCB Pharma
Ascendis Pharma
ChemoCentryx
Axsome Therapeutics
US appetite for Covid-19 treatments remains undiminished
EP Vantage
Thu, 05/27/21 - 10:49 am
FDA
COVID-19
drug approvals
When FDA Makes You An Offer You Can’t Refuse
FDA Law Blog
Wed, 05/26/21 - 12:02 am
FDA
regulatory
drug approvals
CDER
DRG
How pandemic challenges delayed FDA approvals
BioCentury
Thu, 05/6/21 - 10:31 am
FDA
drug approvals
pandemic
COVID-19
Janet Woodcock on if the FDA is getting tougher on drug reviews: ‘I don’t think so’
Endpoints
Wed, 04/14/21 - 09:49 pm
FDA
Janet Woodcock
drug approvals
Drugmakers push the FDA to resume inspections after drug approvals delayed, denied
Beckers Hospital Review
Tue, 03/2/21 - 11:58 pm
FDA
drug approvals
inspections
FDA Hit Record Drug and Biologic Approvals in 2020, Despite Ongoing Pandemic
BioSpace
Wed, 02/3/21 - 10:54 pm
COVID-19
pandemic
FDA
drug approvals
biologics
2020 drug approvals rise despite Covid-19
EP Vantage
Thu, 01/21/21 - 10:34 am
drug approvals
FDA
COVID-19
pandemic
FDA sped progress for most of 2020's novel drugs
RAPS.org
Thu, 01/14/21 - 10:32 pm
FDA
novel drugs
drug approvals
Even before year-end, 2020's new drug approvals match FDA's 2019 stats
RAPS.org
Tue, 12/8/20 - 12:13 am
FDA
drug approvals
pandemic
COVID-19
Drug rejections rise as Covid-19 bites
EP Vantage
Wed, 11/18/20 - 01:20 pm
COVID-19
drug approvals
Alkermes
ALKS 3831
pandemic
regulatory inspections
Study: Few new drugs have high therapeutic value
RAPS.org
Mon, 10/12/20 - 08:17 pm
British Medical Journal
FDA
EMA
therapeutic value
drug approvals
5 FDA approval decisions to watch in the 4th quarter
BioPharma Dive
Wed, 09/30/20 - 10:45 am
FDA
drug approvals
vaccines
Pfizer
Moderna Therapeutics
COVID-19
Regeneron
EB3
ebola virus
Alkermes
ALKS-3831
schizophrenia
bipolar disorder
Bristol-Myers Squibb
liso-cel
non-Hodgkin lymphoma
roxadustat
FibroGen
chronic kidney disease
Another strong year for novel drug approvals is in the making
EP Vantage
Fri, 09/25/20 - 10:50 am
FDA
drug approvals
regulatory
COVID-19 Vaccine May Pit Science Against Politics
NPR
Thu, 08/27/20 - 10:21 am
drug approvals
vaccines
COVID-19
pandemic
politics
Operation Warp Speed
Top FDA official says would resign if agency rubber-stamps an unproven COVID-19 vaccine
Reuters
Fri, 08/21/20 - 12:48 pm
FDA
vaccines
COVID-19
pandemic
drug approvals
2 major FDA rejections leave some pharma investors worried about intensification of regulations
Beckers Hospital Review
Thu, 08/20/20 - 10:51 pm
FDA
drug approvals
drug development
Gilead Sciences
Biomarin

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