drug approvals

EMA concerned about MAA delays, working on solutions
RAPS.org
Wed, 10/2/24 - 09:53 pm
EMA
Europe
drug approvals
FDA inspection backlog overseas threatens new drug approvals
Pharma Voice
Thu, 09/19/24 - 09:23 am
FDA
regulatory inspections
regulatory
drug approvals
FDA approval numbers soar after COVID troubles
Pharmaphorum
Wed, 01/31/24 - 11:51 am
FDA
drug approvals
pandemic
COVID-19
2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer
Fierce Pharma
Tue, 01/2/24 - 10:10 am
FDA
drug approvals
Pfizer
COVID-19
After quitting FDA adcomm in protest of Aduhelm decision, Harvard's Aaron Kesselheim finds agency has an approval bias
Fierce Pharma
Mon, 07/31/23 - 10:07 am
FDA
Biogen
Aduhelm
Alzheimer's disease
advisory committees
drug approvals
Less Than Half of New Drug Approvals Add Therapeutic Value Over Existing Treatments: Study
BioSpace
Thu, 07/6/23 - 09:57 pm
drug approvals
FDA
Europe
The waxing and waning of the speedy approval
EP Vantage
Mon, 05/15/23 - 09:58 am
FDA
drug approvals
accelerated approvals
AbbVie
AstraZeneca
Bayer
Bristol Myers Squibb
JNJ
Merck
Merck KGaA
Novartis
Pfizer
Gene Therapies Are Still Hampered By Substantial Delays Between Approval And Launch
Forbes
Wed, 05/3/23 - 11:48 am
gene therapy
drug approvals
Biomarin
Bluebird Bio
FDA
FDA has new leverage over companies looking for a quicker drug approval
NPR
Fri, 03/3/23 - 10:06 am
FDA
regulatory
accelerated approvals
drug approvals
‘A slippery slope’: A looming nationwide abortion pill ban could undermine the entire drug approval system
Stat
Thu, 02/23/23 - 09:57 am
drug approvals
legislation
mifepristone
abortion pill
UK could allow reciprocal drug approvals with US FDA as soon as 2024
Endpoints
Thu, 02/16/23 - 04:52 pm
regulatory
drug approvals
FDA
UK
Study: 10% of FDA approved drugs since 2018 had pivotal trials that missed primary endpoints
RAPS.org
Mon, 02/13/23 - 10:07 pm
FDA
drug approvals
clinical trials
Can the FDA keep the momentum going for rare disease drug approvals?
Pharmaceutical Technology
Mon, 01/23/23 - 09:57 pm
FDA
Rare Diseases
drug approvals
A year of two halves for US approvals
EP Vantage
Thu, 01/19/23 - 09:38 am
FDA
drug approvals
Mounjaro
Eli Lilly
Vabysmo
Roche
Opdualag
Bristol Myers Squibb
Carvykti
JNJ
Vtama
Roivant
Pluvicto
Novartis
FDA’s Center for Drug Evaluation and Research approved 37 novel drugs in 2022
Medical Marketing and Media
Tue, 01/10/23 - 06:33 pm
FDA
CDER
drug approvals
FDA approves drugs from Gilead, Roche, TG Therapeutics to close 2022
BioPharma Dive
Wed, 01/4/23 - 10:11 am
FDA
drug approvals
HIV
lymphoma
multiple sclerosis
Gilead Sciences
Roche
TG Therapeutics
FDA commissioner on drug approvals: The problem isn't innovation or speed
Endpoints
Thu, 12/8/22 - 11:15 pm
FDA
Robert Califf
innovation
drug approvals
Brace for an end-of-year boost to drug approvals
EP Vantage
Fri, 09/2/22 - 12:14 pm
FDA
drug approvals
Alnylam Pharmaceuticals
Apellis Pharmaceuticals
Bristol Myers Squibb
Eli Lilly
Gilead Sciences
Mirati Therapeutics
Moderna Therapeutics
Provention Bio
Roche
TG Therapeutics
Travere Therapeutics
Biotech Looks to Bounce Back in Second Half of 2022
BioSpace
Mon, 08/22/22 - 09:43 am
biotech
M&A
drug approvals
Drugmakers are slow to prove medicines that got a fast track to market really work
NPR
Sun, 07/24/22 - 07:52 pm
FDA
drug approvals
accelerated approvals
fast track
cancer

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