FDA

FDA Hits Avidity's AOC for Myotonic Dystrophy Type 1 with Partial Hold
BioSpace
Wed, 09/28/22 - 10:38 am
Avidity Biosciences
AOC 1001
myotonic muscular dystrophy
FDA
clinical trials
Vertex given green light to seek US approval of CRISPR-based therapy
BioPharma Dive
Wed, 09/28/22 - 12:01 am
Vertex Pharmaceuticals
CRISPR
CRISPR Therapeutics
FDA
exa-cel
beta thalassemia
sickle cell disease
Seeking sibling for Vyvgart, argenx files for FDA approval of subcutaneous efgartigimod
Fierce Pharma
Tue, 09/27/22 - 10:16 am
Argenx
Vyvgart
myasthenia gravis
efgartigimod
FDA
Philips’ latest BiPAP machine recall labeled Class I event by FDA
Medtech Dive
Mon, 09/26/22 - 10:55 am
devices
Medtech
Philips
BiPAP machines
FDA
device recalls
Pfizer/BioNTech seek FDA nod for new COVID boosters for children
Yahoo/Reuters
Mon, 09/26/22 - 10:39 am
Pfizer
BioNTech
COVID-19
FDA
vaccines
pediatric
boosters
FDA releases draft guidance for protecting children in clinical trials
Clinical Trials Arena
Mon, 09/26/22 - 10:35 am
clinical trials
pediatric
FDA
FDA advisory committee issues back to back negative votes on two cancer drugs
MedCity News
Mon, 09/26/22 - 10:31 am
FDA
Spectrum Pharmaceuticals
Oncopeptides
clinical trials
poziotinib
Pepaxto
Multiple Myeloma
Moderna seeks FDA nod for Omicron-targeted COVID shot for adolescents, younger kids
Yahoo/Reuters
Sun, 09/25/22 - 02:31 pm
Moderna Therapeutics
COVID-19
FDA
boosters
pediatric
vaccines
PI3K inhibitors slammed again as adcom says no to Secura
BioWorld
Sun, 09/25/22 - 02:23 pm
FDA
Secura Bio
Copiktra
Despite being approved in Europe, Oncopeptides' Pepaxto will remain sidelined in the US
Fierce Pharma
Sun, 09/25/22 - 02:00 pm
FDA
Oncopeptides
Multiple Myeloma
Pepaxto
Months after exiting clinical hold, Pfizer readies to resume dosing in phase 3 gene therapy trial
Fierce Biotech
Fri, 09/23/22 - 10:50 am
Pfizer
clinical trials
hemophilia A
gene therapy
FDA
giroctocogene fitelparvovec
FDA panel recommends Ferring's fecal transplant therapy
NASDAQ
Fri, 09/23/22 - 10:47 am
Ferring Pharmaceuticals
fecal transplants
C. difficile
FDA
Medtronic gets first FDA approval for drug-eluting stent in bifurcation lesions
Medtech Dive
Fri, 09/23/22 - 10:42 am
devices
Medtech
Medtronic
FDA
drug-eluting stents
bifurcation
Onyx Frontier
Resolute Onyx
Biogen bolsters case for ALS drug under FDA review with new published data
MedCity News
Fri, 09/23/22 - 10:36 am
Biogen
ALS
FDA
tofersen
FDA panel votes against Spectrum's lung cancer drug
Reuters
Thu, 09/22/22 - 11:54 pm
FDA
Spectrum Pharrmaceuticals
non-small cell lung cancer
poziotinib
'Practically clean' FDA user fees reauth will be included in spending bill wrapping up next week
Endpoints
Thu, 09/22/22 - 11:51 pm
FDA
regulatory
user fees
legislation
FDA slaps hold on DBV peanut allergy trial in call for protocol changes
Fierce Biotech
Thu, 09/22/22 - 10:33 am
DBV Technologies
clinical trials
FDA
peanut allergy
Lilly’s Retevmo receives FDA approval to treat solid tumours
Pharmaceutical Business Review
Thu, 09/22/22 - 10:13 am
Eli Lilly
FDA
Retevmo
solid tumors
metastatic solid tumors
Industry seeks clarity on FDA’s standards recognition process for regenerative medicines
RAPS.org
Wed, 09/21/22 - 07:59 pm
FDA
regulatory
regenerative medicine
Some Medtronic insulin pumps are vulnerable to hackers, FDA warns
Endpoints
Wed, 09/21/22 - 07:58 pm
medronic
insulin pumps
Medtech
devices
diabetes
cybersecurity
cyberattacks
FDA
MiniMed 600

Pages