drug approvals

FDA misses another approval decision target date, this time for GSK's Nucala in COPD
Fierce Pharma
Fri, 05/9/25 - 09:36 am
FDA
HHS
GSK
COPD
Nucala
regulatory
drug approvals
FDA misses approval deadline for biotech’s rare disease drug
BioPharma Dive
Wed, 04/30/25 - 10:55 am
FDA
Stealth BioTherapeutics
drug approvals
Rare Diseases
elamipretide
Barth Syndrome
Makary Discusses Expedited Rare Disease Approvals Pathway, ‘Public Distrust’ in New Interview
BioSpace
Mon, 04/21/25 - 05:56 pm
FDA
Marty Makary
Rare Diseases
drug approvals
regulatory
FDA after the storm: drug review delays and increased executive oversight expected
BioSpace
Mon, 04/14/25 - 11:02 am
FDA
regulatory
HHS
drug approvals
Kennedy’s MAHA agenda is tackling ‘conflicts of interest’ — and could take aim at FDA adcomms
Pharma Voice
Mon, 02/24/25 - 09:57 am
Robert F Kennedy Jr.
HHS
FDA
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

Pages