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» FDA
FDA
FDA grants IND clearance for Allay’s trial of post-surgical pain treatment
Clinical Trials Arena
Thu, 06/13/24 - 10:52 am
Allay Therapeutics
FDA
ATX101
post-surgical pain
Teva Loses Inhaler Patent Case Against Amneal, Must Delete or Amend Orange Book Listing
BioSpace
Wed, 06/12/24 - 11:24 pm
Teva Pharmaceutical
ProAir HFA
FDA
Orange Book
legal
Amneal
Don’t sweat an FDA sIRB mandate in clinical research – It’s good news for everyone
Pharmaphorum
Tue, 06/11/24 - 11:18 am
FDA
sIRB
single institutional review board
R&D
Lilly Alzheimer’s drug gets unanimous backing of FDA panel
BioPharma Dive
Mon, 06/10/24 - 06:09 pm
Eli Lilly
FDA
donanemab
Alzheimer's disease
FDA grants accelerated approval to Genfit and Ipsen's liver disease drug
Reuters
Mon, 06/10/24 - 06:02 pm
Genfit
Ipsen
FDA
Ocaliva
primary biliary cholangitis. liver disease
FDA accepts Eisai's subcutaneous Leqembi filing, sets January 25 decision date
Fierce Pharma
Mon, 06/10/24 - 11:19 am
Eisai
Biogen
Leqembi
FDA
Alzheimer's disease
GSK exec lauds 'great start' to RSV vaccine uptake as Arexvy nabs label expansion in adults 50-59
Fierce Pharma
Sat, 06/8/24 - 01:05 pm
GSK
Arexvy
vaccines
FDA
RSV
Diabetes biotech stock Biomea tanks as FDA imposes full clinical hold
Fierce Biotech
Fri, 06/7/24 - 11:22 am
Biomea Fusion
FDA
clinical trials
diabetes
BMF-219
Geron surges after winning first US FDA approval for blood disorder drug
Reuters
Fri, 06/7/24 - 11:14 am
Geron
Rytelo
FDA
myelodysplastic syndromes
FDA staff raise no major concerns about Eli Lilly Alzheimer's drug
Reuters
Thu, 06/6/24 - 09:11 pm
Eli Lilly
FDA
Alzheimer's disease
donanemab
FDA Accepts for Review Treosulfan NDA Resubmission
BioSpace
Thu, 06/6/24 - 09:07 pm
Medexus
treosulfan
FDA
Medac
stem cell transplant
FDA lays out donanemab concerns ahead of meeting, as Lilly vigorously defends safety
Fierce Biotech
Thu, 06/6/24 - 11:45 am
Eli Lilly
donanemab
FDA
Alzheimer's disease
Moderna’s mRNA Candidate Joins FDA’s Accelerator Program for Rare Diseases
BioSpace
Thu, 06/6/24 - 11:39 am
Moderna Therapeutics
mRNA-3705
FDA
Rare Diseases
START
FDA Panel Recommends New COVID Vaccines For JN.1 Lineage By Fall
Forbes
Wed, 06/5/24 - 10:31 pm
FDA
COVID-19
vaccines
JN.1
Microbot Robotic Surgical System FDA-Approved to Begin Human Trials
Medical Devices and Diagnostics Industry
Wed, 06/5/24 - 11:21 am
Medtech
robotic surgery
Microbot Medical
FDA
Liberty Endovascular
FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns
BioPharma Dive
Tue, 06/4/24 - 11:36 pm
Lykos Therapeutics
FDA
MDMA
psychedelic drugs
FDA panel to review psychedelic drug MDMA for first time
Reuters
Tue, 06/4/24 - 11:40 am
FDA
MDMA
PTSD
psychedelic drugs
Lykos Therapeutics
FDA approves Moderna's RSV vaccine with lower-than-expected efficacy in its label
Reuters
Sun, 06/2/24 - 02:50 pm
Moderna Therapeutics
FDA
RSV
vaccines
Dupixent nears EU approval for COPD, as FDA delays
Pharmaphorum
Fri, 05/31/24 - 10:49 am
Sanofi
Regeneron
Dupixent
COPD
EMA
Europe
FDA
Bristol Myers secures another FDA go-ahead for Breyanzi, this time in mantle cell lymphoma
Fierce Pharma
Thu, 05/30/24 - 11:10 pm
Bristol Myers Squibb
Breyanzi
FDA
mantle cell lymphoma
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