FDA

OTC birth control pill delayed as FDA postpones expert meeting for Perrigo drug
Fierce Pharma
Wed, 10/26/22 - 10:49 am
FDA
Perrigo
Opill
OTC
OTC contraceptive pill
contraceptives
FDA explains why it won't pull Jazz's accelerated approval despite a failed confirmatory trial
Endpoints
Wed, 10/26/22 - 10:34 am
Jazz Pharmaceuticals
FDA
metastatic small cell lung cancer
lung cancer
Zepzelca
As GSK gears up for high-stakes daprodustat panel review, FDA flags some safety concerns
Fierce Pharma
Wed, 10/26/22 - 10:26 am
GSK
anemia
daprodustat
FDA
Halloween adcomm postponed as FDA seeks more Ipsen data on ultra rare disorder drug candidate
Endpoints
Tue, 10/25/22 - 11:09 pm
Ipsen
FDA
fibrodysplasia ossificans progressiva
FDA grants priority review for Daiichi Sankyo’s AML medicine
Pharmaceutical Business Review
Tue, 10/25/22 - 10:37 am
FDA
priority review
Daiichi Sankyo
quizartinib
acute myeloid leukemia
AstraZeneca gets first okay for CTLA4 drug tremelimumab
Pharmaphorum
Mon, 10/24/22 - 10:50 am
AstraZene3ca
tremelimumab
liver cancer
FDA
FDA proposes breakthrough status for devices that address health disparities
RAPS.org
Sun, 10/23/22 - 07:05 pm
FDA
CDRH
breakthrough device
regulatory
Abiomed Crosses a Huge Hurdle with Heart Pumps
Medical Devices and Diagnostics Industry
Sun, 10/23/22 - 07:04 pm
Abiomed
devices
Medtech
Impella
FDA
heart pumps
FDA finalizes multiple endpoints guidance
RAPS.org
Fri, 10/21/22 - 11:05 am
FDA
regulatory
clinical trials
multiple endpoints
FDA’s vaccines chief sees possibility of more Covid boosters — sooner than he’d like
Stat
Fri, 10/21/22 - 11:03 am
FDA
COVID-19
vaccines
boosters
FDA authorizes Novavax’s Covid-19 booster, a first for a protein-based vaccine
MedCity News
Wed, 10/19/22 - 10:56 pm
Novavax
vaccines
COVID-19
boosters
FDA
Adcomm again votes to pull controversial pre-term birth drug from the market
Endpoints
Wed, 10/19/22 - 01:20 pm
FDA
Covis Pharma
Makena
preterm birth
FDA device center guidance priority lists targets COVID, digital health
RAPS.org
Tue, 10/18/22 - 10:03 pm
FDA
COVID-19
digital health
Nevro’s AI-Based Spinal Cord Stimulation Device for Chronic Pain Receives FDA Approval
Xtalks
Tue, 10/18/22 - 11:07 am
Medtech
devices
Nevro
FDA
Senza HFX
chronic pain
Spinal Cord Stimulation
Minerva Shares Plunge After FDA Rejects Schizophrenia Drug Candidate
BioSpace
Tue, 10/18/22 - 11:00 am
Minerva Neurosciences
schizophrenia
FDA
roluperidone
FDA approves single-vial version of GSK's Menveo vaccine, ending need for reconstitution
Fierce Pharma
Tue, 10/18/22 - 10:55 am
GSK
FDA
vaccines
Menveo
meningococcal disease
Adderall supply woes continue as the FDA confirms shortage of immediate release capsules
Endpoints
Mon, 10/17/22 - 11:33 pm
FDA
drug shortages
Adderall
ADHD
FDA opens case to withdraw controversial drug for preterm births
BioPharma Dive
Mon, 10/17/22 - 11:20 pm
FDA
Makena
Covis Pharma
preterm birth
Biogen's ALS ambitions on pause as FDA delays approval decision by 3 months
Fierce Biotech
Mon, 10/17/22 - 10:53 am
Biogen
tofersen
FDA
ALS
FDA grants IND clearance for Phase I trials of Phanes’ cancer antibody
Clinical Trials Arena
Mon, 10/17/22 - 10:31 am
Phanes Therapeutics
PT217
FDA
small cell lung cancer

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