FDA

US WorldMeds' Iwilfin bags FDA nod as 1st oral maintenance treatment for high-risk neuroblastoma
Fierce Pharma
Thu, 12/14/23 - 10:52 pm
US WorldMeds
Iwilfin
FDA
neuroblastoma
First-ever drug application for MDMA finally reaches FDA after near 40-year journey
Fierce Biotech
Thu, 12/14/23 - 09:51 am
FDA
MDMA
psychedelics
Candel (CADL) Rises on FDA's Fast Track Status for CAN-2409
Yahoo/Zacks.com
Thu, 12/14/23 - 09:36 am
Candel Therapeutics
FDA
fast track
CAN-2409
pancreatic cancer
FDA approves Medtronic's system for heart condition
Reuters
Wed, 12/13/23 - 10:05 pm
Medtech
Medtronic
FDA
PulseSelect
pulsed field ablation
atrial fibrillation
FDA Creates Adcomm for Genetic Metabolic Diseases and Potential Treatments
BioSpace
Wed, 12/13/23 - 09:34 am
FDA
advisory committees
genetic metabolic diseases
regulatory
US consumer group seeks stronger warnings on Botox, similar treatments
Reuters
Tue, 12/12/23 - 10:02 am
Public Citizen
FDA
Botox
AbbVie
Revance Therapeutics
Daxxify
Evolus
Jeuveau
Supernus Pharmaceuticals
Myobloc
Galderma
Dysport
ASH: Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy
Fierce Pharma
Mon, 12/11/23 - 10:55 pm
ASH 2023
Abecma
FDA
CAR-T
Bristol Myers Squibb
Novartis gears up for label expansion for Kisqali with Phase III results
Clinical Trials Arena
Mon, 12/11/23 - 11:18 am
Novartis
Kisqali
FDA
clinical trials
early breast cancer
breast cancer
Oncology drugmakers seek the sweet spot between efficacy and tolerability
Pharma Voice
Mon, 12/11/23 - 10:16 am
cancer
oncology
drug development
FDA
FDA approves bluebird's sickle cell disease gene therapy. Can Lyfgenia overcome CRISPR's halo?
Fierce Pharma
Sun, 12/10/23 - 11:15 pm
Bluebird Bio
sickle cell disease
FDA
CRISPR
Lyfgenia
In historic decision, FDA approves a CRISPR-based medicine for treatment of sickle cell disease
Stat
Fri, 12/8/23 - 11:36 am
Vertex Pharmaceuticals
FDA
CRISPR
gene editing
Casgevy
sickle cell disease
FDA Could Approve First CRISPR Treatment Today That Might Cure Sickle Cell
Forbes
Fri, 12/8/23 - 09:54 am
Vertex Pharmaceuticals
Casgevy
FDA
CRISPR
sickle cell disease
FDA clears Becton's less-invasive blood collection device
Reuters
Thu, 12/7/23 - 11:55 am
Becton Dickinson
FDA
blood collection
Medtech
Ipsen/Genfit eye June FDA verdict for liver drug elafibranor
Pharmaphorum
Thu, 12/7/23 - 11:01 am
Genfit
Ipsen
elafibranor
primary biliary cholangitis
FDA
priority review
Novartis hit with FDA letter detailing 'significant' Kymriah manufacturing shortfalls
Fierce Pharma
Thu, 12/7/23 - 10:08 am
Novartis
FDA
Kymriah
CAR-T
drug manufacturing
FDA renews Syapse collaboration to use real-world data in oncology
Clinical Trials Arena
Wed, 12/6/23 - 08:53 pm
FDA
oncology
real world data
Syapse
Novartis receives FDA approval for Fabhalta to treat PNH in adults
Pharmaceutical Business Review
Wed, 12/6/23 - 10:25 am
Novartis
FDA
Fabhalta
iptacopan
PNH
paroxysmal nocturnal hemoglobinuria
Humira Biosimilars Not Gaining Traction Epitomizes Dysfunctional U.S. System
Forbes
Mon, 12/4/23 - 10:14 am
Humira
AbbVie
biosimilars
FDA
Lilly Wins Second Accelerated Approval for Reversible BTK Inhibitor
BioSpace
Mon, 12/4/23 - 09:41 am
Eli Lilly
FDA
Jaypirca
CLL
small lymphocytic leukemia
Btk inhibitors
FDA starts review of Padcev/Keytruda for bladder cancer
Pharmaphorum
Fri, 12/1/23 - 09:35 am
Merck
Astellas
Seagen
Padcev
bladder cancer
FDA
priority review

Pages