FDA

FDA staff hold ‘major concerns’ with Brainstorm ALS therapy, documents show
BioPharma Dive
Mon, 09/25/23 - 11:52 am
Brainstorm Cell Thearpaueics
ALS
stem cells
FDA
NurOwn
FDA Regulatory Gauntlet Isn’t Getting Any Easier, Just Ask These Companies
BioSpace
Sun, 09/24/23 - 08:52 pm
FDA
ARS Pharmaceuticals
Novartis
Taysha
Alvotech
Intarcia
FDA greenlights Jardiance for treating chronic kidney disease
Medical Marketing and Media
Fri, 09/22/23 - 11:50 am
Eli Lilly
Boehringer Ingelheim
Medicare
Jardiance
FDA
chronic kidney disease
FDA panel votes against diabetes implant due to safety concerns
Reuters
Fri, 09/22/23 - 11:48 am
Intarcia
diabetes
FDA
ITCA 650
Medtech
Merck (MRK) Keytruda Cervical Cancer sBLA Gets FDA Priority Tag
Yahoo/Zacks.com
Thu, 09/21/23 - 06:32 pm
Merck
Keytruda
FDA
cervical cancer
priority review
Third Time Might Be a Charm for Alvotech as FDA Accepts BLA for Humira Biosimilar
BioSpace
Thu, 09/21/23 - 11:53 am
Alvotech
FDA
biosimilars
AVT02
AbbVie
Humira
Mesoblast Sees Path Forward for Twice-Rejected Cell Therapy After FDA Meeting
BioSpace
Thu, 09/21/23 - 10:38 am
Mesoblast
remestemcel-L
FDA
graft vs host disease
Intarcia, a failed diabetes "unicorn," could be resurrected
Axios
Wed, 09/20/23 - 11:17 pm
Intarcia
FDA
diabetes
Alvotech gets new FDA review for Humira biosimilar
BioPharma Dive
Wed, 09/20/23 - 11:07 pm
Alvotech
FDA
Humira
biosimilars
Taysha ends work on gene therapy after Astellas walks away, FDA requests randomized trial
Fierce Biotech
Wed, 09/20/23 - 08:47 am
Astellas
Taysha Gene Therapies
gene therapy
FDA
FDA Rejects Nasal Spray For Severe Allergic Reactions—Delaying First Needle-Free EpiPen Alternative
Forbes
Wed, 09/20/23 - 08:30 am
ARS Pharmaceuticals
FDA
epinephrine nasal spray
Neffy
allergic reactions
FDA's single-trial guidance calls for the good, bad and ugly data to support effectiveness
Fierce Biotech
Tue, 09/19/23 - 10:23 pm
FDA
clinical trials
regulatory
Inside the FDA's Form 483 findings at Novo Nordisk's North Carolina semaglutide plant
Fierce Pharma
Tue, 09/19/23 - 10:19 pm
Novo Nordisk
FDA
drug manufacturing
semaglutide
North Carolina
Pfizer's 'entrenched' tafamidis franchise will be tough to challenge for Alnylam, BridgeBio: analysts
Fierce Pharma
Mon, 09/18/23 - 08:01 pm
Pfizer
BridgeBio
Alnylam
FDA
clinical trials
ATTR-CM
physicians
tafamidis
Novo Nordisk Dives After FDA Reportedly Finds 'Objectionable' Conditions At A Key Wegovy Plant
Investors Business Daily
Mon, 09/18/23 - 07:58 pm
Novo Nordisk
drug manufacturing
FDA
Wegovy
FDA revises biosimilar guidelines for clearer drug labelling
Pharmaceutical Technology
Mon, 09/18/23 - 07:50 pm
FDA
biosimilars
labeling
Orchard nears FDA decision on rare disease gene therapy
BioPharma Dive
Mon, 09/18/23 - 12:25 pm
Orchard Therapeutics
gene therapy
metachromatic leukodystrophy
FDA
In pleasant surprise for GSK, FDA approves Jakafi challenger Ojjaara in broad blood cancer use
Fierce Pharma
Sun, 09/17/23 - 09:47 pm
GSK
FDA
Ojaara
momelotinib
myelofibrosis
FDA capacity forces delay to Iovance's cell therapy
Pharmaphorum
Fri, 09/15/23 - 11:47 am
Iovance Biotherapeutics
lifileucel
cell therapy
FDA
melanoma
Despite FDA doubts, Alnylam wins expert backing for Onpattro expansion into rare heart disease
Fierce Pharma
Thu, 09/14/23 - 09:59 am
Alnylam
FDA
Onpattro
ATTR-CM

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