FDA

Proposed legislation takes aim at prescription drug advertising
RAPS.org
Mon, 07/11/22 - 05:51 pm
FDA
legislation
pharma advertising
pharma ads
regulatory
Florida Gov. DeSantis hints at suing FDA over stalled Canadian drug import plan
Endpoints
Mon, 07/11/22 - 10:38 am
Florida
Canada
Ron DeSantis
drug importation
FDA
FDA grants fast track designation for Anthos’ cancer associated thrombosis therapy
Pharmaceutical Business Review
Mon, 07/11/22 - 10:26 am
Anthos Therapeutics
Factor XI inhibitor
abelacimab
fast track
FDA
cancer
Drugmaker seeks FDA approval of over-the-counter birth control pill
Stat
Mon, 07/11/22 - 10:25 am
HRA Pharma
contraceptives
oral contraceptives
FDA
Women's Health
FDA is letting pharmacists prescribe Pfizer's Paxlovid but won't do the same for Merck's Lagevrio
Fierce Pharma
Fri, 07/8/22 - 10:59 am
Pfizer
Merck
Paxlovid
Lagevrio
FDA
pharmacists
COVID-19
Amid drug pricing debate, feds reveal effort to crack down on 'incremental' patents
Fierce Pharma
Thu, 07/7/22 - 06:28 pm
FDA
PTO
patents
incremental patents
Two years after CRL, Intercept will meet with FDA later this month to discuss new analysis of NASH drug
Endpoints
Thu, 07/7/22 - 10:28 am
Intercept Pharma
OCA
obeticholic acid
FDA
NASH
Pharmacists Can Prescribe Pfizer’s Covid Antiviral Paxlovid, FDA Says
Forbes
Wed, 07/6/22 - 11:48 pm
FDA
Pfizer
Paxlovid
COVID-19
FDA Has Ways to Go to Keep Pace with 2020/21 Approvals
BioSpace
Wed, 07/6/22 - 11:05 am
FDA
drug approvals
Amicus
Bluebird Bio
Bristol Myers Squibb
Eli Lilly
Marinus Pharma
Amylyx
Novartis
FDA to decide on Roche’s lymphoma drug Lunsumio before year-end
Pharmaforum
Wed, 07/6/22 - 10:49 am
Roche
Lunsumio
follicular lymphoma
T-cell engager
FDA
priority review
Vertex, continuing its rebound, cleared to resume testing of diabetes cell therapy
BioPharma Dive
Wed, 07/6/22 - 10:33 am
Vertex Pharmaceuticals
type 1 diabetes
cell therapy
FDA
Biogen-Eisai go for another biomarker approval in Alzheimer's with lecanemab—and snag priority review
Fierce Biotech
Tue, 07/5/22 - 11:58 pm
Biogen
Eisai
FDA
biomarkers
Alzheimer's disease
lecanemab
Supreme Court Decision On EPA Could Have Implications For Other Regulatory Agencies, Like FDA
Forbes
Tue, 07/5/22 - 11:49 am
regulatory
Supreme Court
FDA
FDA to reconvene experts' meeting for Amylyx ALS drug
Yahoo/Reuters
Tue, 07/5/22 - 10:48 am
Amylyx
ALS
FDA
AMX0035
Hyloris' Post-Op Pain Treatment Maxigesic IV Stalled by CRL from FDA
BioSpace
Mon, 07/4/22 - 11:54 pm
Hyloris Pharmaceuticals
FDA
Maxigesic IV
post-operative pain
Déjà vu: FDA rejects NRx filing for emergency use in COVID-19
Fierce Biotech
Fri, 07/1/22 - 09:39 am
NRx
aviptadil
FDA
COVID-19
Little biotech makes deep cuts as it struggles to get narcolepsy drug approved amid months of regulatory limbo
Endpoints
Fri, 07/1/22 - 09:38 am
Avadel
FDA
nacrolepsy
layoffs
FT218
Provention’s embattled diabetes med delayed again by FDA to consider new info
Fierce Biotech
Thu, 06/30/22 - 10:15 pm
Provention Bio
teplizumab
FDA
diabetes
FDA adds some fresh senior leadership with new chief scientist, chief medical officer
Endpoints
Thu, 06/30/22 - 10:09 pm
FDA
regulatory
FDA steers updated vaccine to focus on dominant omicron subvariants
Beckers Hospital Review
Thu, 06/30/22 - 10:08 pm
FDA
vaccines
COVID-19
Omicron BA.4
Omicron BA.5

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