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drug approvals
The Pentagon’s compromise: drug approvals to remain in FDA’s hands
Endpoints
Thu, 11/16/17 - 07:25 pm
FDA
drug approvals
FDA Sets Monthly ANDA Records in October
RAPS.org
Wed, 11/15/17 - 10:34 am
FDA
ANDAs
generics
drug approvals
Nearly Half of Recent EU Approvals Based on a Single Pivotal Study
RAPS.org
Sat, 11/11/17 - 11:07 am
drug approvals
EU
Europe
China may relax trial requirements for new drugs, allowing foreign data
Fierce Biotech
Mon, 10/9/17 - 09:39 am
China
drug approvals
devices
The FDA Is Approving Drugs at a Staggering Pace
Bloomberg
Sun, 10/8/17 - 11:28 am
FDA
drug approvals
Study Finds FDA Action on Unapproved Drugs Led to Higher Prices, Longer Shortages
RAPS.org
Thu, 09/28/17 - 11:12 am
FDA
drug approvals
drug pricing
FDA: 30 Percent of Drugs Used in Expanded Access Programs are Later Approved
RAPS.org
Wed, 09/20/17 - 11:13 pm
FDA
expanded access programs
drug approvals
New study of FDA cites the flaws behind rapid-fire cancer drug OKs
Endpoints
Wed, 08/16/17 - 11:14 am
FDA
drug approvals
cancer
oncology
Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate
RAPS.org
Thu, 08/10/17 - 06:51 pm
drug approvals
FDA
priority review
accelerated approvals
fast track
breakthrough status
FDA's Flashing Green Light Boosts Novel Drug Approvals
Seeking Alpha
Thu, 07/20/17 - 06:03 pm
FDA
drug approvals
Gilead Sciences
Puma Biotechnology
Vosevi
Nerlynx
FDA Speeding Generic Drug Approvals: Not Just Lip Service
RAPS.org
Mon, 07/10/17 - 11:15 pm
FDA
generics
drug approvals
Scott Gottlieb
Is FDA Too Slow? Researchers Debunk Claims
RAPS.org
Tue, 07/4/17 - 11:00 pm
FDA
drug approvals
9 Biotech Stats That Will Blow You Away
Motley Fool
Mon, 06/12/17 - 10:13 pm
biotech
drug development
R&D
drug approvals
Can Alkermes' Latest Approval Spark a Rally?
Motley Fool
Wed, 06/7/17 - 11:25 am
Alkermes
drug approvals
Aristada
schizophrenia
Accelerated FDA approval and pricey drugs make a rotten combo, doctors argue
Fierce Pharma
Thu, 05/25/17 - 11:26 am
FDA
drug approvals
physicians
drug pricing
Nearly every $100,000 drug approved in the last three years was for a rare disease
Medical Marketing and Media
Thu, 05/25/17 - 09:31 am
Rare Diseases
drug approvals
drug pricing
Drugs approved with limited data aren’t always well-tested later
Reuters
Tue, 05/23/17 - 08:02 am
FDA
drug approvals
The complete response letter: The mail no one wants to receive
Chemical Engineering News
Mon, 05/15/17 - 01:31 pm
FDA
CRL
drug approvals
FDA drug testing doesn’t have to sacrifice safety, or animals, for speed
Stat
Thu, 05/11/17 - 11:19 am
FDA
drug trials
animals
drug approvals
Trump wants faster FDA action, but 1 in 3 drugs have safety issues after approval
Stat
Tue, 05/9/17 - 10:41 pm
Donald Trump
FDA
drug safety
drug approvals
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