FDA

FDA Deems Recall of Stolen Medtronic Laryngoscopes as Class I
Medical Devices and Diagnostics Industry
Mon, 11/13/23 - 11:04 pm
Medtech
Medtronic
laryngoscopes
product recalls
device recalls
FDA
Takeda Wins First FDA Approval for Ultra-Rare Blood Clotting Disease
BioSpace
Fri, 11/10/23 - 10:12 am
Takeda
FDA
ADAMTS13
Adzynma
cogenital thrombocytopenic purpura
Inovio, with path to market opening up, drafts accelerated approval talking points ahead of FDA meeting
Fierce Biotech
Fri, 11/10/23 - 10:08 am
Inovio Pharmaceuticals
Rare Diseases
INO-3107
DNA
FDA
FDA approves Valneva's chikungunya vaccine
Reuters
Thu, 11/9/23 - 11:39 pm
Valneva
vaccines
chikungunya virus
FDA
Ixchiq
Takeda Wins FDA Approval for Fruquintinib in Certain Colorectal Cancer Patients
BioSpace
Thu, 11/9/23 - 09:48 am
Takeda
fruquintinib
FDA
colorectal cancer
FDA Approves Eli Lilly’s Zepbound for Chronic Weight Management
BioSpace
Wed, 11/8/23 - 10:05 pm
Eli Lilly
Zepbound
FDA
weightloss
FDA Accepts sBLA for Interchangeability Designation for Humira biosimilars
Dermatology Times
Wed, 11/8/23 - 09:55 pm
Samsung Bioepis
Organon
FDA
AbbVie
Humira
biosimilars
As Vertex preps for exa-cel launch, exec touts 'very large' opportunity but tempers early expectations
Fierce Pharma
Tue, 11/7/23 - 11:47 am
Vertex Pharmaceuticals
CRISPR
gene editing
FDA
exa-cel
As trial miss threatens FDA approval, Travere points to Filspari's benefits in bid to stay in kidney disease
Fierce Pharma
Fri, 11/3/23 - 10:53 am
Travere Therapeutics
Filspari
IgA nephropathy
kidney disease
FDA
Phathom passes acid tests, capturing 2 FDA approvals for Voquezna after impurity setback
Fierce Pharma
Thu, 11/2/23 - 05:13 pm
Phathom Pharmaceuticals
FDA
Voquezna
H. pylori
GERD
FDA Lifts Hold on Mersana’s Antibody-Drug Conjugate Following Patient Death
BioSpace
Thu, 11/2/23 - 11:42 am
Mersana Therapeutics
XMT-2056
clinical trials
FDA
antibody drug conjugate
Amgen scores FDA approval for Stelara biosimilar
Pharmaceutical Technology
Wed, 11/1/23 - 10:16 pm
Amgen
Stelara
biosimilars
JNJ
FDA
Wezlana
FDA approves Novartis Cosentyx as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decade
Yahoo Finance
Wed, 11/1/23 - 10:14 pm
Novartis
Cosentyx
FDA
hidrad
FDA holds firm on 60-day comment period for lab-developed test rule
Medtech Dive
Wed, 11/1/23 - 10:09 pm
Medtech
diagnostics
laboratory-developed tests
FDA
FDA grants IND clearance for ovarian cancer trial of Oncoinvent
Clinical Trials Arena
Wed, 11/1/23 - 10:12 am
Oncoinvent
FDA
Radspherin
ovarian cancer
FDA panel says Vertex/CRISPR to assess safety risks of gene therapy in follow-up study
Yahoo/Reuters
Tue, 10/31/23 - 09:23 pm
Vertex Pharmaceuticals
CRISPR Therapeutics
FDA
gene therapy
exa-cel
Sarepta’s disappointing data put the FDA in a difficult spot
Stat
Tue, 10/31/23 - 10:16 am
Sarepta Therapeutics
Duchenne Muscular Dystrophy
DMD
FDA
gene therapy
Tracking the FDA’s meeting on Vertex, CRISPR’s sickle cell therapy
BioPharma Dive
Tue, 10/31/23 - 10:13 am
FDA
Vertex Pharmaceuticals
CRISPR
sickle cell disease
exa-cel
Sarepta gene therapy for Duchenne misses main goal of key study
BioPharma Dive
Mon, 10/30/23 - 08:17 pm
Sarepta Therapeutics
gene therapy
Duchenne Muscular Dystrophy
clinical trials
FDA
Elevidys
FDA Flags Off-Target Effects of Vertex, CRISPR’s Sickle Cell Therapy Ahead of Adcomm
BioSpace
Mon, 10/30/23 - 08:09 pm
Vertex Pharmaceuticals
exa-cel
CRISPR
sickle cell disease
FDA

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