FDA

FDA to review Emergent's OTC opioid overdose drug on priority
Reuters
Wed, 12/7/22 - 09:48 am
Emergent BioSolutions
opioid overdose
FDA
OTC
Narcan
FDA Class I device recall events ticked up in FY 2022
RAPS.org
Tue, 12/6/22 - 08:48 pm
Medtech
devices
FDA
Class I recall
regulatory
Karuna switches CEOs ahead of FDA filing for schizophrenia drug
BioPharma Dive
Tue, 12/6/22 - 08:45 pm
Karuna Therapeutics
Pharma CEOs
schizophrenia
FDA
KarXT
FDA grants fast track designation for IDEAYA’s uveal melanoma therapy
Pharmaceutical Business Review
Tue, 12/6/22 - 10:29 am
IDEAYA Biosciences
darovasertib
uveal melanoma
FDA
FDA Outlines Path Forward for Verve’s Lead Candidate, VERVE-101
BioSpace
Mon, 12/5/22 - 10:55 pm
Verve Therapeutics
VERVE-101
FDA
heterozygous familial hypercholesterolemia
A Change Is Coming for Abiomed’s Impella RP System Indication
Medical Devices and Diagnostics Industry
Mon, 12/5/22 - 10:44 pm
devices
Medtech
Abiomed
Impella RP
FDA
In free fall, Clovis defaults on loan and agrees to further restrict Rubraca use
Fierce Pharma
Mon, 12/5/22 - 11:07 am
Clovis Oncology
Rubraca
FDA
ovarian cancer
Do Verve's gene edits pass down to patients' children? The FDA wants to know
Fierce Biotech
Mon, 12/5/22 - 10:42 am
Verve Therapeutics
gene editing
gene therapy
FDA
VERVE-101
This Week at FDA: FDA approves first FMT product, upcoming mpox guidance, and more
RAPS.org
Sun, 12/4/22 - 01:29 pm
FDA
regulatory
mpox
Ferring Pharmaceuticals
microbiome
COVID-19
Eli Lilly
Beam jumps back into off-the-shelf CAR-T race after FDA lifts clinical hold
Fierce Biotech
Fri, 12/2/22 - 11:03 am
Beam Therapeutics
FDA
CAR-T
clinical trials
BEAM-201
FDA remains silent on orphan drug exclusivity after last year's court loss
Endpoints
Thu, 12/1/22 - 07:09 pm
FDA
orphan drug exclusivity
orphan drugs
Switzerland eyes allowing FDA-approved medical devices onto its market
RAPS.org
Thu, 12/1/22 - 07:01 pm
Switzerland
devices
Medtech
FDA
FDA approves first fecal microbiome drug, setting stage for others
Stat
Thu, 12/1/22 - 10:41 am
Ferring Pharmaceuticals
Rebyota
FDA
C. difficile
fecal microbiome
microbiome
Lilly's Covid-19 mAb no longer authorized due to Omicron subvariants, FDA says
Endpoints
Wed, 11/30/22 - 08:04 pm
Eli Lilly
FDA
COVID-19
Omicron
bebtelovimab
monoclonal antibodies
Lexicon slams FDA over hearing denial following a CRL for its SGLT2 inhibitor candidate
Endpoints
Wed, 11/30/22 - 08:01 pm
Lexicon Pharmaceuticals
FDA
type 1 diabetes
sotagliflozin
Bluebird Bio Sells Priority Review Voucher For $102M, Strengthening Its Financial Position
Benzinga
Wed, 11/30/22 - 10:47 am
Bluebird Bio
priority review vouchers
FDA
Argenx
Go or no go? Mirati heads to the FDA
EP Vantage
Wed, 11/30/22 - 10:34 am
FDA
Mirati Therapeutics
Gilead Sciences
Coherus Biosciences
Roche
Biogen
TG Therapeutics
Ipsen
Novartis
BeiGene
Cytokinetics
FDA looks to modeling and simulation tools to streamline product reviews
RAPS.org
Tue, 11/29/22 - 11:08 am
FDA
regulatory
simulation
product reviews
FDA grants speedy review to Sarepta’s Duchenne gene therapy
BioPharma Dive
Tue, 11/29/22 - 10:50 am
Sarepta Therapeutics
SRP-9001
FDA
Duchenne Muscular Dystrophy
Resistance to FDA’s opioid-disposal plan raises concerns about CADCA, a powerful advocacy group
Stat
Tue, 11/29/22 - 10:34 am
opioids
FDA
CADCA

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