FDA

FDA details switch to electronic filings for 510(k), de novo submissions
Medtech Dive
Wed, 10/4/23 - 09:46 am
FDA
Medtech
de novo pathway
devices
FDA authorizes Novavax’s updated Covid-19 vaccine
Stat
Tue, 10/3/23 - 07:25 pm
Novavax
COVID-19
vaccines
FDA
FDA staff says late-stage data 'not enough' for Amgen's lung cancer drug
Reuters
Tue, 10/3/23 - 10:23 am
Amgen
FDA
Lumakras
lung cancer
With FDA nod for rare disease drug Rivfloza, Novo Nordisk eyes showdown with Alnylam
Fierce Pharma
Mon, 10/2/23 - 06:36 pm
Novo Nordisk
Rivfloza
FDA
primary hyperoxaluria type 1
RNAi
Alnylam
5 FDA decisions to watch in the fourth quarter
BioPharma Dive
Mon, 10/2/23 - 12:00 pm
FDA
Alnylam
Onpattro
ATTR amyloidosis
Vertex Pharmaceuticals
CRISPR Therapeutics
exa-cel
Bluebird Bio
Zynteglo
sickle cell disease
Bristol Myers Squibb
2seventy bio
Abecma
Multiple Myeloma
Amgen
Lumakras
non-small cell lung cancer
Pfizer
estrasimod
ulcerative colitis
FDA Rejects Lilly’s Eczema Treatment Over Third-Party Manufacturing Issues
BioSpace
Mon, 10/2/23 - 10:36 am
Eli Lilly
lebrikizumab
atopic dermatitis
eczema
FDA
drug manufacturing
FDA Gives Okay to DNA Test for Common Hereditary Cancers
OBR Oncology
Mon, 10/2/23 - 10:09 am
Invitae
Common Hereditary Cancers Panel
DNA
diagnostics
Medtech
FDA
FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies
Applied Clinical Trials Online
Sun, 10/1/23 - 02:30 pm
FDA
Rare Diseases
clinical trials
drug development
Path for BrainStorm ALS Treatment Remains Rocky, Hope for Others on Horizon
BioSpace
Sun, 10/1/23 - 01:05 pm
FDA
BrainStorm Cell Therapeutics
NurOwn
Seelos Therapeutics
Takeda
Clene
FDA could furlough nearly one-fifth of staff by Sunday
RAPS.org
Thu, 09/28/23 - 11:50 pm
FDA
government shutdown
regulatory
Takeda’s Entyvio receives FDA approval for subcutaneous administration
Pharmaceutical Technology
Thu, 09/28/23 - 11:46 pm
Takeda
Entyvio
ulcerative colitis
FDA
FDA gives Merck priority review for blood vessel disorder therapy sotatercept
Medical Marketing and Media
Thu, 09/28/23 - 11:42 pm
Merck
PAH
sotatercept
FDA
Exxua Charts a New Path in Depression Treatment Following FDA Nod
Xtalks
Thu, 09/28/23 - 11:38 pm
Fabre-Kramer Pharmaceuticals
FDA
Exxua
major depressive disorder
depression
Karuna submits schizophrenia drug for US approval
BioPharma Dive
Thu, 09/28/23 - 12:02 pm
Karuna Therapeutics
KarXT
schizophrenia
FDA
FDA approves Amicus Therapeutics' muscle disorder treatment
Reuters
Thu, 09/28/23 - 11:56 am
Amicus Therapeutics
FDA
Pompe disease
AT-GAA
FDA Adds New Warning for Ileus to Ozempic Label
HCP Live
Thu, 09/28/23 - 11:55 am
Novo Nordisk
Ozempic
diabetes
weight losss
FDA
ileus
labeling
FDA Adcomm Rejects BrainStorm’s ALS Therapy in Nearly Unanimous Vote
BioSpace
Wed, 09/27/23 - 11:21 pm
BrainStorm Cell Therapeutics
FDA
ALS
NurOwn
FDA warns manufacturers to test for contaminants tied to global deaths
Beckers Hospital Review
Wed, 09/27/23 - 11:19 pm
FDA
contamination
drug manufacturing
FDA finalizes guidance on cybersecurity for medical devices
Medtech Dive
Wed, 09/27/23 - 11:48 am
FDA
cybersecurity
Coherus hits FDA hurdles for PD-1 drug, Neulasta biosimilar on-body injector
Fierce Pharma
Mon, 09/25/23 - 07:56 pm
Coherus Biosciences
Neulasta
biosimilars
FDA
Junshi Biosciences

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