FDA

FDA's Peter Marks backs accelerated approval for gene therapies
BioSpace
Tue, 03/21/23 - 11:36 am
FDA
CDER
Peter Marks
gene therapy
accelerated approval
FDA grants fast track designation to Arrowhead Pharmaceuticals’ ARO-APOC3 to reduce triglycerides
Pharmaceutical Business Review
Tue, 03/21/23 - 09:57 am
Arrowhead Pharmaceuticals
ARO-APOC3
triglycerides
familial chylomicronemia syndrome
fast track
FDA
FDA’s top cybersecurity officials discuss heightened threats, technology modernization
RAPS.org
Tue, 03/21/23 - 09:53 am
FDA
cybersecurity
modernization
Olympus Smacked with One Doozy of a Warning Letter
Medical Devices and Diagnostics Industry
Mon, 03/20/23 - 04:34 pm
FDA
devices
Medtech
Olympus
Neurofilament as a surrogate endpoint goes on trial in tofersen adcomm
BioSpace
Mon, 03/20/23 - 11:40 am
ALS
Biogen
Ionis Pharmaceuticals
FDA
tofersen
clinical trials
FDA's Robert Califf calls on insurers to help providers participate in critical clinical drug trials
Fierce Healthcare
Mon, 03/20/23 - 10:01 am
Robert Califf
FDA
insurers
clinical trials
Pear Therapeutics Looks For A Buyer As It Struggles To Get Paid For Prescription Apps
Forbes
Sun, 03/19/23 - 01:40 pm
Pear Therapeutics
digital therapeutics
FDA
Medtech
insomnia
M&A
Novartis' Tafinlar/Mekinist combo scores new indication in pediatric brain cancer
Endpoints
Sun, 03/19/23 - 01:36 pm
Novartis
Tafinlar
Mekinist
pediatric
brain cancer
FDA
FDA agrees to give Ipsen's rare disease drug another look as palovarotene saga rumbles on
Fierce Biotech
Sun, 03/19/23 - 01:34 pm
Ipsen
FDA
palovarotene
fibrodysplasia ossificans progressiva
FDA Reverses Course; Will Hold Adcomm for Sarepta’s DMD Gene Therapy
BioSpace
Fri, 03/17/23 - 10:13 am
FDA
Sarepta Therapeutics
DMD
gene therapy
Duchenne Muscular Dystrophy
SRP-9001
FDA adcomm votes in favor of Pfizer's Covid-19 pill Paxlovid
Endpoints
Thu, 03/16/23 - 06:18 pm
FDA
Pfizer
Paxlovid
antivirals
COVID-19
Duchenne muscular dystrophy: major trials and events to watch in 2023
Clinical Trials Arena
Thu, 03/16/23 - 09:49 am
DMD
Duchenne Muscular Dystrophy
clinical trials
gene therapy
FDA
Sarepta Therapeutics
SRP-9001
FibroGen
pamrevlumab
Capricor
CAP-1002
Santhera
ReveraGen
vamorolone
FDA offers radio silence on question of spring Covid boosters, as other countries push ahead
Stat
Thu, 03/16/23 - 09:41 am
FDA
boosters
vaccines
COVID-19
Pfizer (PFE) Gets FDA Nod for Bivalent COVID Shot in Young Children
Yahoo/Zacks.com
Thu, 03/16/23 - 09:25 am
Pfizer
BioNTech
FDA
pediatric
COVID-19
bivalent boosters
vaccines
FDA staff report says data shows Pfizer’s Covid treatment Paxlovid is effective in high-risk adults
CNBC
Tue, 03/14/23 - 06:26 pm
Pfizer
Paxlovid
COVID-19
FDA
antivirals
FDA pauses Mersana’s clinical trial after patient dies
Endpoints
Mon, 03/13/23 - 10:54 am
Mersana
clinical trials
FDA
patient death
cancer
XMT-2056
antibody-drug conjugate
FDA schedules adcomms for Entasis' antimicrobial treatment, Intercept's NASH hopeful
Endpoints
Mon, 03/13/23 - 10:19 am
FDA
Entasis
Intercept Pharma
sulbactam-durlobactam
obeticholic acid
NASH
Acadia wins first FDA approval for Rett syndrome drug
Endpoints
Mon, 03/13/23 - 10:04 am
Acadia Pharmaceuticals
FDA
Daybue
Rett Syndrome
FDA will phase out 22 Covid-19 guidance documents as emergency declaration expires
Endpoints
Sun, 03/12/23 - 09:52 pm
COVID-19
regulatory
FDA
GAO to FDA: Do more to encourage drug manufacturing innovation
Endpoints
Sun, 03/12/23 - 09:49 pm
FDA
GAO
innovation
drug manufacturing

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