FDA

Eisai starts rolling submission for injectable version of Alzheimer's drug with US FDA
Reuters
Tue, 05/14/24 - 11:03 pm
Eisai
Biogen
Leqembi
FDA
Alzheimer's disease
FDA delays decision on Moderna's RSV shot until the end of May
Fierce Biotech
Fri, 05/10/24 - 11:44 am
Moderna Therapeutics
FDA
RSV
vaccines
mRNA-1345
Preventing '3 billion visits' to FDA a year with CBER's Peter Marks
Fierce Biotech
Wed, 05/8/24 - 10:57 pm
FDA
CBER
Peter Markes
ASGCT
House lawmaker brings FDA into biosecurity crackdown on China
Fierce Pharma
Wed, 05/8/24 - 11:36 am
FDA
China
biosecurity
Robert Califf
FDA advisers to weigh first psychedelic therapy in early June
Fierce Biotech
Tue, 05/7/24 - 11:23 am
Lykos Therapeutics
FDA
MDMA
Lykos
psychedelic drugs
advisory committees
Lilly gets a date with FDA to discuss Alzheimer's med donanemab
Fierce Biotech
Tue, 05/7/24 - 11:21 am
Eli Lilly
FDA
advisory committees
Alzheimer's disease
donanemab
Vertex files FDA approval ask for next-gen cystic fibrosis candidate, resumes diabetes cell therapy trial
Fierce Biotech
Tue, 05/7/24 - 11:14 am
Vertex Pharmaceuticals
cystic fibrosis
Vanza Triple
FDA
gene therapy
Eli Lilly Gears Up for Donanemab Adcomm as FDA Ponders Changes to Format
BioSpace
Mon, 05/6/24 - 11:43 am
Eli Lilly
FDA
donanemab
advisory committees
Alzheimer's disease
FDA’s Accelerated Approval of Sarepta DMD Gene Therapy Comes Under Fire
BioSpace
Fri, 05/3/24 - 11:20 am
FDA
accelerated approvals
Sarepta Therapeutics
DMD
gene therapy
Apple gets FDA okay to use AFib tool in clinical trials
Pharmaphorum
Fri, 05/3/24 - 11:15 am
Medtech
Apple
Apple Watch
atrial fibrillation
FDA
clinical trials
FDA Approval Fuels Boehringer’s Biosimilar Challenge to AbbVie’s Humira
BioSpace
Thu, 05/2/24 - 11:37 am
Boehringer Ingelheim
Cyltezo
AbbVie
Huira
FDA
biosimilars
As AI proliferates in pharma, regulators look to catch up in clinical trials
Pharma Voice
Wed, 05/1/24 - 09:27 am
FDA
clinical trials
artificial intelligence
Neurocrine Biosciences' Huntington's disease drug gets FDA approval
Reuters
Tue, 04/30/24 - 06:27 pm
Neurocrine Biosciences
FDA
Ingrezza
Huntington's disease
Prime editing comes of age as FDA clears human trials
Pharmaphorum
Tue, 04/30/24 - 08:28 am
Prime Medicine
prime editing
FDA
clinical trials
FDA finalizes lab developed test rule over industry opposition
BioPharma Dive
Mon, 04/29/24 - 11:03 pm
FDA
diagnostics
in vitro diagnostics
FDA grants full approval for Pfizer's cervical cancer drug
Reuters
Mon, 04/29/24 - 11:01 pm
Pfizer
cervical cancer
FDA
Tivdak
Abbott Dissolving Stent Granted Earlier-Than-Expected FDA Approval
Medical Devices and Diagnostics Industry
Mon, 04/29/24 - 10:58 pm
Medtech
Abbott Labs
Esprit Everolimus
limb-threatening ischemia
FDA
FDA calls for adcomm to discuss Novo Nordisk's filing for weekly insulin
Fierce Pharma
Mon, 04/29/24 - 11:22 am
Novo Nordisk
Awiqli
weekly insulin
FDA
diabetes
insulin icodec
insulin
FDA approves X4 Pharmaceuticals' therapy for immunodeficiency disease
Reuters
Mon, 04/29/24 - 11:04 am
X4 Pharmaceuticals
FDA
Xolremdi
WHIM syndrome
Pfizer hemophilia gene therapy arrives in US to uncertain future
BioPharma Dive
Fri, 04/26/24 - 11:15 am
Pfizer
gene therapy
FDA
hemophila B
Beqvez

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