FDA

FDA clears 1st OTC continuous glucose monitor
Beckers Hospital Review
Wed, 03/6/24 - 11:22 am
Medtech
DexCom
Stelo Glucose Biosensor
CGMs
blood glucose monitoring
FDA
diabetes
FDA advisory panel recommends a streamlined flu vaccine for next fall
Stat
Tue, 03/5/24 - 10:21 pm
FDA
vaccines
flu vaccine
Vanda's jet lag approval hopes for Hetlioz quashed with FDA hearing rejection
Fierce Pharma
Tue, 03/5/24 - 10:14 pm
Vanda Pharmaceuticals
Hetlioz
jet lag disorder
FDA
Eyenovia, Formosa Win FDA Approval for Anti-Inflammatory Eye Drops
BioSpace
Tue, 03/5/24 - 11:32 am
Eyenovia
Formosa Pharmaceuticals
FDA
clobetasol propionate
eye surgery
Hugel Aesthetics Breaks Into US Market with Letybo: A New Challenger for Botox
BNN
Mon, 03/4/24 - 11:50 pm
Hugel
Letybo
Botox
AbbVie
FDA
Iovance receives more good news as FDA lifts hold on lung cancer cell therapy trial
Fierce Biotech
Mon, 03/4/24 - 11:50 am
Iovance Biotherapeutics
FDA
LN-145
lung cancer
cell therapy
clinical trials
J&J Wins Full FDA Approval for Rybrevant, Chemo Combo in NSCLC
BioSpace
Mon, 03/4/24 - 11:48 am
JNJ
FDA
bispecific antibodies
Rybrevant
non-small cell lung cancer
FDA lifts two-year clinical hold on CytoDyn’s HIV trial
Clinical Trials Arena
Fri, 03/1/24 - 11:49 am
FDA
CytoDyn
clinical trials
HUV
leronlimab
FDA approves Boston Scientific's drug-coated heart device
Reuters
Fri, 03/1/24 - 11:19 am
Boston Scientific
FDA
Medtech
Agent
drug-coated balloon catheter
FDA finds problems at animal lab run by Musk’s brain implant company
Reuters
Thu, 02/29/24 - 11:15 am
Neuralink
Elon Musk
animal research
FDA
brain implants
EMA and FDA green-light MoonLake to advance IL-17 inhibitor
Clinical Trials Arena
Wed, 02/28/24 - 09:38 pm
MoonLake Immunotherapeutics
sonelokimab
FDA
EMA
hidradenitis suppurativa
Virtual Incision wins FDA de novo nod for miniaturized surgical robot
Medtech Dive
Wed, 02/28/24 - 11:03 am
Medtech
Virtual Incision
FDA
robotic surgery
colon resection
Minerva schizophrenia drug rejected by FDA
BioPharma Dive
Tue, 02/27/24 - 11:17 pm
Minerva
schizophrenia
FDA
roluperidone
FDA warns of potential risk from Hologic's devices implanted in soft tissue
Reuters
Tue, 02/27/24 - 11:15 pm
Medtech
FDA
Hologic
devices
implants
Bayer wins FDA breakthrough therapy designation for NSCLC candidate
Clinical Trials Arena
Mon, 02/26/24 - 05:16 pm
FDA
Bayer
breakthrough designation
non-small cell lung cancer
BAY 2927088
FDA Rescinds Approval of Oncopeptides' Blood Cancer Treatment: Implications and What's Next
Medriva
Mon, 02/26/24 - 10:44 am
Oncopeptides
Pepaxto
FDA
Multiple Myeloma
Sanofi, Regeneron Secure FDA Priority Review for Dupixent in COPD
BioSpace
Fri, 02/23/24 - 10:43 am
FDA
Sanofi
Regeneron
Dupixent
priority review
COPD
FDA Urges Independent Verification of Third-Party Testing Data
Medical Devices and Diagnostics Industry
Wed, 02/21/24 - 10:37 pm
FDA
Medtech
third party data
United Therapeutics starts litigation with FDA over rival Liquidia's drug application
Reuters
Wed, 02/21/24 - 11:13 am
United Therapeutics
FDA
Liquidia
Treprostinil
pulmonary hypertension
US, EU regulators start swift reviews of Servier glioma drug
Pharmaphorum
Wed, 02/21/24 - 11:09 am
FDA
EMA
Servier
vorasidenib
glioma
brain cancer

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