FDA

After prior rejection, Iterum nabs long-sought FDA nod for oral UTI drug Orlynvah
Fierce Pharma
Sun, 10/27/24 - 07:48 pm
Iterum
antibiotics
UTIs
FDA
Orlynvah
GSK answers Pfizer's RSV approval with data targeting matching nod in younger adults
Fierce Pharma
Thu, 10/24/24 - 10:58 am
GSK
Arexvy
vaccines
RSV
Pfizer
FDA
FDA’s GLP-1 decision kicks off ‘unprecedented’ tussle over shortage
BioPharma Dive
Wed, 10/23/24 - 11:40 am
FDA
GLP-1 agonists
drug shortages
compounding pharmacies
Sangamo slashes time to market for Fabry gene therapy as FDA agrees to accelerated approval package
Fierce Biotech
Wed, 10/23/24 - 11:33 am
Sangamo Therapeutics
Fabry disease
FDA
ST-920
FDA names Tarver as new head of device center
Biopharma Reporter
Tue, 10/22/24 - 11:26 pm
Medtech
FDA
devices
Michelle Tarver
CDRH
Adcentrx gets FDA clearance for phase 1 trial of ADC for tumors
Biopharma Reporter
Tue, 10/22/24 - 11:31 am
Adcentrx
solid tumors
clinical trials
FDA
ADRX-0405
FDA declines to approve Camurus' rare hormone disorder drug
Reuters
Tue, 10/22/24 - 11:24 am
Camurus
FDA
CAM2029
acromegaly
Lykos accepts FDA’s view that reviving rejected MDMA therapy’s fortunes requires fresh phase 3 trial
Fierce Biotech
Mon, 10/21/24 - 09:48 am
Lykos Therapeutics
MDMA
FDA
FDA’s GLP-1 decision kicks off ‘unprecedented’ tussle over shortage
Pharma Voice
Mon, 10/21/24 - 09:37 am
FDA
GLP-1 agonists
Ozempic
Wegovy
Novo Nordisk
drug shortages
Eli Lilly
Zepbound
Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer med Vyloy
Fierce Pharma
Sun, 10/20/24 - 10:22 pm
Astellas
FDA
Vyloy
gastric cancer
Medtronic MiniMed 600 and 700 Series Pump Recall Dubbed FDA Class I
Medical Devices and Diagnostics Industry
Sun, 10/20/24 - 10:17 pm
Medtech
Medtronic
device recalls
MiniMed 600
MiniMed 700
FDA
FDA Pushes Back PDUFA Dates for Amgen and Intercept
BioSpace
Fri, 10/18/24 - 11:28 am
FDA
Amgen
Lumakras
colorectal cancer
Intercept Pharma
Ocaliva
primary biliary cholangitis
Helene and CVS land double whammy for 25,000 patients who survive on IV nutrition
Medical Marketing and Media
Fri, 10/18/24 - 10:19 am
Medtech
FDA
IVs
hurricane
CVS Health
CMR Surgical gets FDA de novo nod for Versius robot
Medtech Dive
Fri, 10/18/24 - 10:13 am
CMR Surgical
Medtech
FDA
Versius
gallbladder removal
robotic surgery
After rejections, AbbVie secures approval for Parkinson’s drug
BioPharma Dive
Thu, 10/17/24 - 08:52 pm
AbbVie
Parkinson's Disease
Vyalev
FDA
FDA extends review of Obeticholic Acid (Ocaliva) sNDA for primary biliary cholangitis
HCP Live
Thu, 10/17/24 - 08:28 pm
Ocaliva
Intercept Pharma
primary biliary cholangitis
FDA
Glaukos eyes FDA approval for ocular therapy after Phase III win
Clinical Trials Arena
Thu, 10/17/24 - 08:22 pm
Glaukos
FDA
clinical trials
keratoconus
Epioxa
Novocure wins FDA approval for electric field device in lung cancer
BioPharma Dive
Wed, 10/16/24 - 05:22 pm
Novocure
Optune Luna
Medtech
FDA
non-small cell lung cancer
J&J makes surgical robotic moves with Ottava FDA IDE application
Clinical Trials Arena
Wed, 10/16/24 - 12:31 pm
Medtech
JNJ
IDE
FDA
robotic surgery
Ottava
FDA pauses Novavax's trial of combo COVID-flu shot on safety concerns
Reuters
Wed, 10/16/24 - 10:00 am
FDA
Novavax
clinical trials
COVID-flu vaccines
vaccines

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