FDA

FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies
FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies
Applied Clinical Trials Online
FDA
Rare Diseases
clinical trials
drug development
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Path for BrainStorm ALS Treatment Remains Rocky, Hope for Others on Horizon
Path for BrainStorm ALS Treatment Remains Rocky, Hope for Others on Horizon
BioSpace
FDA
BrainStorm Cell Therapeutics
NurOwn
Seelos Therapeutics
Takeda
Clene
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FDA could furlough nearly one-fifth of staff by Sunday
FDA could furlough nearly one-fifth of staff by Sunday
RAPS.org
FDA
government shutdown
regulatory
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Takeda’s Entyvio receives FDA approval for subcutaneous administration
Takeda’s Entyvio receives FDA approval for subcutaneous administration
Pharmaceutical Technology
Takeda
Entyvio
ulcerative colitis
FDA
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FDA gives Merck priority review for blood vessel disorder therapy sotatercept
FDA gives Merck priority review for blood vessel disorder therapy sotatercept
Medical Marketing and Media
Merck
PAH
sotatercept
FDA
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Exxua Charts a New Path in Depression Treatment Following FDA Nod
Exxua Charts a New Path in Depression Treatment Following FDA Nod
Xtalks
Fabre-Kramer Pharmaceuticals
FDA
Exxua
major depressive disorder
depression
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Karuna submits schizophrenia drug for US approval
Karuna submits schizophrenia drug for US approval
BioPharma Dive
Karuna Therapeutics
KarXT
schizophrenia
FDA
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FDA approves Amicus Therapeutics' muscle disorder treatment
FDA approves Amicus Therapeutics' muscle disorder treatment
Reuters
Amicus Therapeutics
FDA
Pompe disease
AT-GAA
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FDA Adds New Warning for Ileus to Ozempic Label
FDA Adds New Warning for Ileus to Ozempic Label
HCP Live
Novo Nordisk
Ozempic
diabetes
weight losss
FDA
ileus
labeling
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FDA Adcomm Rejects BrainStorm’s ALS Therapy in Nearly Unanimous Vote
FDA Adcomm Rejects BrainStorm’s ALS Therapy in Nearly Unanimous Vote
BioSpace
BrainStorm Cell Therapeutics
FDA
ALS
NurOwn
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FDA warns manufacturers to test for contaminants tied to global deaths
FDA warns manufacturers to test for contaminants tied to global deaths
Beckers Hospital Review
FDA
contamination
drug manufacturing
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FDA finalizes guidance on cybersecurity for medical devices
FDA finalizes guidance on cybersecurity for medical devices
Medtech Dive
FDA
cybersecurity
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Coherus hits FDA hurdles for PD-1 drug, Neulasta biosimilar on-body injector
Coherus hits FDA hurdles for PD-1 drug, Neulasta biosimilar on-body injector
Fierce Pharma
Coherus Biosciences
Neulasta
biosimilars
FDA
Junshi Biosciences
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FDA staff hold ‘major concerns’ with Brainstorm ALS therapy, documents show
FDA staff hold ‘major concerns’ with Brainstorm ALS therapy, documents show
BioPharma Dive
Brainstorm Cell Thearpaueics
ALS
stem cells
FDA
NurOwn
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FDA Regulatory Gauntlet Isn’t Getting Any Easier, Just Ask These Companies
FDA Regulatory Gauntlet Isn’t Getting Any Easier, Just Ask These Companies
BioSpace
FDA
ARS Pharmaceuticals
Novartis
Taysha
Alvotech
Intarcia
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FDA greenlights Jardiance for treating chronic kidney disease
FDA greenlights Jardiance for treating chronic kidney disease
Medical Marketing and Media
Eli Lilly
Boehringer Ingelheim
Medicare
Jardiance
FDA
chronic kidney disease
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FDA panel votes against diabetes implant due to safety concerns
FDA panel votes against diabetes implant due to safety concerns
Reuters
Intarcia
diabetes
FDA
ITCA 650
Medtech
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Merck (MRK) Keytruda Cervical Cancer sBLA Gets FDA Priority Tag
Merck (MRK) Keytruda Cervical Cancer sBLA Gets FDA Priority Tag
Yahoo/Zacks.com
Merck
Keytruda
FDA
cervical cancer
priority review
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Third Time Might Be a Charm for Alvotech as FDA Accepts BLA for Humira Biosimilar
Third Time Might Be a Charm for Alvotech as FDA Accepts BLA for Humira Biosimilar
BioSpace
Alvotech
FDA
biosimilars
AVT02
AbbVie
Humira
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Mesoblast Sees Path Forward for Twice-Rejected Cell Therapy After FDA Meeting
Mesoblast Sees Path Forward for Twice-Rejected Cell Therapy After FDA Meeting
BioSpace
Mesoblast
remestemcel-L
FDA
graft vs host disease
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