FDA

Lilly shares full pivotal data on Alzheimer’s drug, revealing how it shapes up against Leqembi
Fierce Biotech
Mon, 07/17/23 - 06:51 pm
Eli Lilly
Alzheimer's disease
clinical trials
FDA
donanemab
Boston Scientific’s New Deep Brain Stimulation Software Gets FDA Nod
Xtalks
Mon, 07/17/23 - 09:13 am
Boston Scientific
Medtech
deep brain stimulation
Vercise Deep Brain Stimulation System
FDA
Parkinson's Disease
FDA grants approval for Veklury use in Covid-19 patients with severe renal impairment
Pharmaceutical Business Review
Mon, 07/17/23 - 10:01 am
Gilead Sciences
COVID-19
FDA
Veklury
remdesivir
CEL-SCI's multi-decade Multikine journey extends with FDA request for new trial
Fierce Biotech
Sun, 07/16/23 - 03:08 pm
Cel-Sci
Multikine
head and neck cancer
FDA
clinical trials
MIT researchers to lead a new center for continuous mRNA manufacturing
MIT News
Thu, 07/13/23 - 09:05 pm
MIT
FDA
MRNA
FDA approves Opill, the first OTC birth control pill in the U.S.
Medical Marketing and Media
Thu, 07/13/23 - 11:41 am
Opill
Perrigo
OTC contraceptive pill
oral contraceptives
FDA
FDA by the Numbers: 2023 Mid-Year Review
Medical Devices and Diagnostics Industry
Thu, 07/13/23 - 10:12 am
Medtech
FDA
devices
510(k)
FDA to import more Chinese cancer drugs amid shortage
The Hill
Wed, 07/12/23 - 09:32 am
FDA
China
Cisplatin
drug shortages
cancer
chemotherapy
Takeda withdraws FDA approval application for dengue vaccine
BioPharma Dive
Tue, 07/11/23 - 11:22 pm
Takeda
FDA
dengue
vaccines
More, but slower, medtech approvals
EP Vantage
Tue, 07/11/23 - 10:08 am
FDA
Medtech
devices
device approvals
Leqembi Wins Full FDA Approval as First Anti-Amyloid Antibody for Alzheimer’s
BioSpace
Thu, 07/6/23 - 10:08 pm
Biogen
Eisai
Leqembi
FDA
Alzheimer's disease
Less Than Half of New Drug Approvals Add Therapeutic Value Over Existing Treatments: Study
BioSpace
Thu, 07/6/23 - 09:57 pm
drug approvals
FDA
Europe
Sarepta sells FDA priority review voucher to mystery buyer for $102M as prices continue to slip
Fierce Pharma
Thu, 07/6/23 - 11:15 am
Sarepta Therapeutics
priority review vouchers
FDA
Is Regeneron's Stock in Trouble After This FDA Rejection?
Motley Fool
Thu, 07/6/23 - 10:15 am
Regeneron
Eylea
FDA
Roche pulls a Gavreto approval before Blueprint severance, citing unfeasible trial
Fierce Pharma
Wed, 07/5/23 - 07:12 pm
Roche
Blueprint Medicines
cancer
Gavreto
accelerated approvals
FDA
Amneal’s long-acting Parkinson’s drug gets cold shoulder from FDA
Medical Marketing and Media
Wed, 07/5/23 - 07:03 pm
Amneal Pharmaceuticals
FDA
Parkinson's Disease
IPX203
Abbott wins FDA nod for first dual-chamber leadless pacemaker
Mass Device
Wed, 07/5/23 - 10:35 am
Abbott Labs
Aveir
dual-chamber leadless pacemaker
FDA
Medtech
9 Highly Anticipated FDA Decisions in Second Half of 2023
BioSpace
Fri, 06/30/23 - 11:52 am
FDA
Eisai
Biogen
Leqembi
Alzheimer's disease
SAGE Therapeutics
zuranolone
postpartum depression
major depressive disorder
Roche
Tecentriq
non-small cell lung cancer
CRISPR Therapeutics
Bluebird Bio
lovo-cel
exa-cel
BrainStorm Cell Therapeutics
NurOwn
Alvotech to raise cash after third FDA rejection for Humira biosimilar
BioPharma Dive
Fri, 06/30/23 - 11:39 am
Alvotech
Teva Pharmaceutical
AbbVie
Humira
biosimilars
FDA
Ipsen and Genfit to file for EMA and FDA approval for elafibranor
Clinical Trials Arena
Fri, 06/30/23 - 10:12 am
Ipsen
Genfit
EMA
FDA
elafibranor
liver disease
primary biliary cholangitis

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