FDA

AstraZeneca's Ultomiris scores its 3rd FDA approval, setting up market clash with argenx
Fierce Pharma
Thu, 04/28/22 - 11:05 am
AstraZeneca
Ultomiris
FDA
myasthenia gravis
Could This FDA Approval Be a Boost for Merck?
Motley Fool
Thu, 04/28/22 - 11:04 am
Merck
Keytruda
FDA
endometrial cancer
Y-mAbs' longtime CEO steps down abruptly as FDA reviews second pediatric cancer drug
Endpoints
Thu, 04/28/22 - 11:01 am
Y-mAbs Therapeutics
Pharma CEOs
FDA
Claus Moller
FDA clears Pfizer to restart Duchenne gene therapy trial, with new safeguards
BioPharma Dive
Thu, 04/28/22 - 10:56 am
Pfizer
gene therapy
Duchenne Muscular Dystrophy
clinical trial
FDA
Burr chastises FDA at second Senate user fee hearing
RAPS.org
Wed, 04/27/22 - 10:41 am
regulatory
devices
MDUFA
FDA
Medtech
FDA officials: Firms with strong quality cultures more resilient to data integrity problems
RAPS.org
Tue, 04/26/22 - 10:35 pm
FDA
data
regulatory
data integrity
Pfizer asks FDA to authorize booster shots for kids ages 5 through 11
NPR
Tue, 04/26/22 - 10:21 pm
Pfizer
FDA
boosters
vaccines
pediatric
COVID-19
FDA approves first COVID treatment for children under 12
Axios
Mon, 04/25/22 - 11:02 pm
FDA
Gilead Sciences
Veklury
remdesivir
pediatric
FDA plans study into how patients and physicians make prescription decisions
Fierce Pharma
Mon, 04/25/22 - 10:56 pm
FDA
physicians
patients
OPDP
FDA warns small biotech Ocugen of potential $10K fines for failing to post trial results
Endpoints
Mon, 04/25/22 - 10:46 am
FDA
regulatory
clinical trials
Ocugen
vaccines
COVID-19
Axsome expects migraine drug to be rejected as manufacturing issues arise
Endpoints
Mon, 04/25/22 - 10:42 am
Axsome Therapeutics
migraines
FDA
AXS-07
After 18 years in development, AstraZeneca’s CTLA-4 antibody gets the red carpet treatment at the FDA
Endpoints
Mon, 04/25/22 - 10:20 am
AstraZeneca
FDA
tremelimumab
liver cancer
priority review
The FDA Will Soon Give These 3 Healthcare Companies the Green Light
Motley Fool
Sat, 04/23/22 - 03:54 pm
Novavax
vaccines
COVID-19
Axsome Therapeutics
FDA
Novocure
lung cancer
FDA plots multi-day hearing to review 'dangling' accelerated approval that drugmaker refuses to pull
Endpoints
Sat, 04/23/22 - 03:50 pm
FDA
accelerated approvals
Covis Pharma
60 Scientists Sign Letter Petitioning FDA for T Cell Recognition
BioSpace
Sat, 04/23/22 - 03:47 pm
FDA
T-cells
COVID-19
vaccines
FDA proposes plan to mail back unused opioids
RAPS.org
Fri, 04/22/22 - 10:38 am
FDA
REMS
opioids
Ampio slumps as FDA delivers knee osteoarthritis shock
Pharmaforum
Fri, 04/22/22 - 10:24 am
Ampio Pharmaceuticals
osteoarthritis of the knee
FDA
Ampion
FDA's ODAC votes unanimously that future PI3K inhibitors should include randomized data for blood cancers
Endpoints
Thu, 04/21/22 - 11:32 pm
FDA
PI3k inhibitor
On heels of psych drug approval, BioXcel dives head first into oncology R&D with new cash infusion
Endpoints
Thu, 04/21/22 - 10:53 am
BioXcel
FDA
Igalmi
Medtech Industry: FDA emergency product shortage reporting guidance is too broad, burdensome
RAPS.org
Wed, 04/20/22 - 11:27 pm
FDA
Medtech
regulatory
devices
device shortages

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