FDA

CBO finds Senate's FDA user fee bill will reduce the federal deficit by about $1.4B
Endpoints
Thu, 07/21/22 - 09:52 pm
FDA
regulatory
CBO
user fees
Gilead doubles down on HIV prevention, treatment amid Covid setbacks and awaiting FDA decision on long-acting candidate
Endpoints
Thu, 07/21/22 - 09:46 pm
Gilead
HIV
FDA
Staffing shortage could be hindering controversial Paxlovid clearance
Beckers Hospital Review
Thu, 07/21/22 - 09:35 pm
Pfizer
Paxlovid
COVID-19
antivirals
FDA
pharmacists
Pfizer, Gilead and others seek clarifications on trial designs outlined in FDA's UC and Crohn's draft guidance
Endpoints
Thu, 07/21/22 - 10:38 am
Pfizer
Gilead Sciences
Big Pharma
ulcerative colitis
Crohn's Disease
drug development
FDA
What This FDA Delay Means for Novartis
Motley Fool
Thu, 07/21/22 - 10:36 am
Novartis
FDA
cancer
tislelizumab
Smiths Medical’s recall of syringe infusion pumps labeled Class I event after injuries, death
Medtech Dive
Thu, 07/21/22 - 10:31 am
devices
Medtech
Smiths Medical
device recalls
FDA
infusion pumps
After Regulatory Bumps, Apex Wins FDA Nod Renuvion
Medical Devices and Diagnostics Industry
Wed, 07/20/22 - 11:22 pm
Apex Medical
FDA
Renuvion
Medtech
devices
aesthetics
Jazz’s toehold on sleep market slips with tentative Avadel FDA approval
BioSpace
Wed, 07/20/22 - 10:31 am
Jazz Pharma
Avadel
Lumryz
excessive daytime sleepiness
sleep disorders
patents
FDA
After rejection, Azurity gets FDA nod for liquid epilepsy drug
Fierce Pharma
Tue, 07/19/22 - 10:30 am
Azurity
FDA
zonisamide
epilepsy
Apellis Surges By Double Digits As FDA Mulls Its Eye-Disease Treatment
Investors Business Daily
Tue, 07/19/22 - 10:14 am
Apellis Pharmaceuticals
geographic atrophy
FDA
pegcetacoplan
FDA Action Alert: Incyte, Arcutis Await Decisions in Vitiligo, Psoriasis
BioSpace
Mon, 07/18/22 - 10:22 am
FDA
Incyte
Arcutis Biotherapeutics
Opzelura
vitiligo
roflumilast
psoriasis
FDA faces furloughs if Senate misses August deadline for user fee bill
Medtech Dive
Mon, 07/18/22 - 09:51 am
FDA
Senate
legislation
user fees
Pfizer's Xalkori picks up FDA nod for rare ALK-positive tumors
Fierce Pharma
Fri, 07/15/22 - 11:01 am
Pfizer
FDA
Xalkori
Drug shortages remain low in 2021 as FDA's prevention efforts grow, report to Congress says
Endpoints
Thu, 07/14/22 - 07:56 pm
drug shortages
FDA
supply chain
Krystexxa Chronic Gout Medication Gets Expanded FDA Approval
Xtalks
Thu, 07/14/22 - 07:53 pm
Horizon Therapeutics
Krystexxa
gout
FDA
FDA Indefinitely Delays BeiGene/Novartis anti-PD-1 Esophageal Cancer Drug
BioSpace
Thu, 07/14/22 - 10:51 am
Novartis
BeiGene
FDA
tislelizumab
esophageal cancer
FDA authorizes Novavax Covid vaccine, in hopes the traditional shot will convince holdouts
Stat
Wed, 07/13/22 - 08:26 pm
Novavax
COVID-19
vaccines
FDA
FDA chief says US has 'got to do better' at generating medical product data
Fierce Biotech
Wed, 07/13/22 - 08:24 pm
FDA
accelerated approvals
Robert Califf
FDA rule would facilitate prescription-to-OTC switches but nix a third class of drugs
Stat
Tue, 07/12/22 - 11:37 pm
FDA
regulatory
OTC
Aldeyra says eye drop clears three dry eye signals en route to FDA
Endpoints
Tue, 07/12/22 - 10:51 am
Aldeyra Therapeutics
dry eye disease
FDA
clinical trials
reproxalap

Pages