FDA

AACR: Study Suggests Accelerated Approval Doesn’t Always Lead to Clinical Benefit
BioSpace
Wed, 04/10/24 - 05:44 pm
AACR
oncology
FDA
accelerated approvals
FDA gives nod to BrainStorm for ALS trial after Phase III flop
Clinical Trials Arena
Tue, 04/9/24 - 11:39 am
BrainStorm Cell Therapeutics
clinical trials
NurOwn
FDA
ALS
As FDA weighs another myeloma endpoint for accelerated approvals, experts say timely access is at stake
Fierce Pharma
Tue, 04/9/24 - 11:36 am
FDA
Multiple Myeloma
Ten doctors on FDA panel reviewing Abbott heart device had financial ties with company
Medical Marketing and Media
Mon, 04/8/24 - 05:48 pm
Medtech
Abbott Labs
FDA
TriClip G4
FDA grants breakthrough status to Dizal’s sunvozertinib
Pharmaceutical Business Review
Mon, 04/8/24 - 11:54 am
Dizal Pharmaceutical
FDA
non-small cell lung cancer
sunvozertinib
FDA swats away Supernus’ Parkinson’s disease infusion pump for 3rd time
Fierce Pharma
Mon, 04/8/24 - 11:07 am
Medtech
FDA
Supernus
Parkinson's Disease
FDA grants accelerated approval to Enhertu for metastatic HER2-positive cancers
Investing.com
Sun, 04/7/24 - 04:45 pm
AstraZeneca
Daiichi Sankyo
FDA
Enhertu
solid tumors
House committee to press FDA Commissioner Robert Califf on shortage oversight, other issues
Fierce Pharma
Fri, 04/5/24 - 11:36 am
FDA
Robert Califf
drug shortages
What Abbott’s Big FDA Approval Means for the Tricuspid Device Market
Medical Devices and Diagnostics Industry
Thu, 04/4/24 - 11:21 am
Medtech
Abbott Labs
TriClip
FDA
MitraClip
tricuspid valve regurgitation
US FDA approves Basilea Pharmaceutica's antibiotic
Marketscreener
Wed, 04/3/24 - 10:37 pm
Basilea
antibiotics
FDA
antibiotic resistance
'We're open for business': FDA's Peter Marks says agency ready to review novel cancer vaccines despite unknowns
Fierce Biotech
Wed, 04/3/24 - 10:30 pm
Peter Marks
FDA
cancer vaccine
Moderna Therapeutics
Merck
MRNA
mRNA-4157
FDA approves Vanda's drug for treatment of bipolar disorder
Reuters
Tue, 04/2/24 - 09:57 pm
Vanda Pharmaceuticals
bipolar disorder
FDA
Fanapt
D&D Pharmatech Granted Fast Track Designation from US FDA for DD01 for the Treatment of NASH/MASH
BioSpace
Tue, 04/2/24 - 11:37 am
D&D Pharmatech
DD01
MASH
NASH
FDA
fast track
Abbott's heart valve repair device gets US approval
Reuters
Tue, 04/2/24 - 11:18 am
Medtech
Abbott Labs
TriClip
tricuspid valve regurgitation
FDA
AstraZeneca Gets FDA Approval in Boost to Rare Disease Franchise
BioSpace
Mon, 04/1/24 - 11:58 am
AstraZeneca
FDA
rare disease
danicopan
PNH
Cybin CEO on FDA breakthrough designation for psychedelic drug treating MDD
Medical Marketing and Media
Mon, 04/1/24 - 11:48 am
Cybin
FDA
psychedelics
major depressive disorder
FDA approves Gilead's Vemlidy drug for children with hepatitis B
Investing.com
Thu, 03/28/24 - 05:08 pm
Gilead Sciences
FDA
Vemlidy
hepatitis B
pediatric
Medtronic’s Newest Generation Evolut FX+ System Nabs FDA Nod
Medical Devices and Diagnostics Industry
Wed, 03/27/24 - 10:35 pm
Medtech
Medtronic
Evolut FX+
TAVR
FDA
FDA approves Akebia's anemia drug
Reuters
Wed, 03/27/24 - 10:32 pm
Akebia
FDA
vadadustat
chronic kidney disease
Merck scores key FDA approval for pulmonary arterial hypertension drug Winrevair
Fierce Pharma
Wed, 03/27/24 - 11:22 am
Merck
FDA
PAH
Winrevair
sotatercept
Acceleron

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