drug approvals

After quitting FDA adcomm in protest of Aduhelm decision, Harvard's Aaron Kesselheim finds agency has an approval bias
After quitting FDA adcomm in protest of Aduhelm decision, Harvard's Aaron Kesselheim finds agency has an approval bias
Fierce Pharma
FDA
Biogen
Aduhelm
Alzheimer's disease
advisory committees
drug approvals
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Less Than Half of New Drug Approvals Add Therapeutic Value Over Existing Treatments: Study
Less Than Half of New Drug Approvals Add Therapeutic Value Over Existing Treatments: Study
BioSpace
drug approvals
FDA
Europe
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The waxing and waning of the speedy approval
The waxing and waning of the speedy approval
EP Vantage
FDA
drug approvals
accelerated approvals
AbbVie
AstraZeneca
Bayer
Bristol Myers Squibb
JNJ
Merck
Merck KGaA
Novartis
Pfizer
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Gene Therapies Are Still Hampered By Substantial Delays Between Approval And Launch
Gene Therapies Are Still Hampered By Substantial Delays Between Approval And Launch
Forbes
gene therapy
drug approvals
Biomarin
Bluebird Bio
FDA
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FDA has new leverage over companies looking for a quicker drug approval
FDA has new leverage over companies looking for a quicker drug approval
NPR
FDA
regulatory
accelerated approvals
drug approvals
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‘A slippery slope’: A looming nationwide abortion pill ban could undermine the entire drug approval system
‘A slippery slope’: A looming nationwide abortion pill ban could undermine the entire drug approval system
Stat
drug approvals
legislation
mifepristone
abortion pill
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UK could allow reciprocal drug approvals with US FDA as soon as 2024
UK could allow reciprocal drug approvals with US FDA as soon as 2024
Endpoints
regulatory
drug approvals
FDA
UK
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Study: 10% of FDA approved drugs since 2018 had pivotal trials that missed primary endpoints
Study: 10% of FDA approved drugs since 2018 had pivotal trials that missed primary endpoints
RAPS.org
FDA
drug approvals
clinical trials
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Can the FDA keep the momentum going for rare disease drug approvals?
Can the FDA keep the momentum going for rare disease drug approvals?
Pharmaceutical Technology
FDA
Rare Diseases
drug approvals
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A year of two halves for US approvals
A year of two halves for US approvals
EP Vantage
FDA
drug approvals
Mounjaro
Eli Lilly
Vabysmo
Roche
Opdualag
Bristol Myers Squibb
Carvykti
JNJ
Vtama
Roivant
Pluvicto
Novartis
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FDA’s Center for Drug Evaluation and Research approved 37 novel drugs in 2022
FDA’s Center for Drug Evaluation and Research approved 37 novel drugs in 2022
Medical Marketing and Media
FDA
CDER
drug approvals
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FDA approves drugs from Gilead, Roche, TG Therapeutics to close 2022
FDA approves drugs from Gilead, Roche, TG Therapeutics to close 2022
BioPharma Dive
FDA
drug approvals
HIV
lymphoma
multiple sclerosis
Gilead Sciences
Roche
TG Therapeutics
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FDA commissioner on drug approvals: The problem isn't innovation or speed
FDA commissioner on drug approvals: The problem isn't innovation or speed
Endpoints
FDA
Robert Califf
innovation
drug approvals
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Brace for an end-of-year boost to drug approvals
Brace for an end-of-year boost to drug approvals
EP Vantage
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
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Biotech Looks to Bounce Back in Second Half of 2022
Biotech Looks to Bounce Back in Second Half of 2022
BioSpace
biotech
M&A
drug approvals
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Drugmakers are slow to prove medicines that got a fast track to market really work
Drugmakers are slow to prove medicines that got a fast track to market really work
NPR
FDA
drug approvals
accelerated approvals
fast track
cancer
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FDA Has Ways to Go to Keep Pace with 2020/21 Approvals
FDA Has Ways to Go to Keep Pace with 2020/21 Approvals
BioSpace
FDA
drug approvals
Amicus
Bluebird Bio
Bristol Myers Squibb
Eli Lilly
Marinus Pharma
Amylyx
Novartis
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BIO research outlines risks in changing accelerated approval pathway
BIO research outlines risks in changing accelerated approval pathway
Biopharma Reporter
BIO Conference
FDA
drug approvals
accelerated approvals
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Study: FDA approves new oncology drugs quicker than EMA
Study: FDA approves new oncology drugs quicker than EMA
RAPS.org
JAMA
regulatory
drug approvals
FDA
EMA
Europe
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FDA Approvals Roundup: Camzyos, Vivjoa, Epsolay
FDA Approvals Roundup: Camzyos, Vivjoa, Epsolay
RAPS.org
FDA
drug approvals
Bristol Myers Squibb
Camzyos
Mycovia
Vivjoa
Sol-Gel
Epsolay
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