FDA

Bi-weekly dose of Johnson & Johnson's blood cancer therapy gets US FDA approval
Reuters
Tue, 02/20/24 - 05:54 pm
JNJ
Tecvayli
FDA
Multiple Myeloma
Daiichi Sankyo and AstraZeneca’s lung cancer antibody set for FDA review
Clinical Trials Arena
Tue, 02/20/24 - 11:30 am
Daiichi Sankyo
AstraZeneca
FDA
Tagrisso
non-small cell lung cancer
RAPT Therapeutics Shares Plunge Premarket on FDA Study Hold
Morningstar
Tue, 02/20/24 - 11:17 am
RAPT Therapeutics
clinical trials
FDA
zelnecirnon
asthma
atopic dermatits
FDA starts review of Argenx drug in rare disease CIDP
Pharmaphorum
Tue, 02/20/24 - 11:01 am
Argenx
Vygart Hytrulo
CIDP
FDA
FDA approves Iovance's Amtagvi as first T-cell therapy for a solid tumor
Fierce Pharma
Sun, 02/18/24 - 08:39 pm
Iovance
FDA
Amtagvi
solid tumors
t-cell therapies
cell therapy
Pacira publishes data showing Exparel reduces opioid use
Clinical Trials Arena
Sun, 02/18/24 - 08:33 pm
EXPAREL
FDA
Pacira
opioids
FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies
Fierce Pharma
Sun, 02/18/24 - 08:31 pm
Roche
Novartis
Xolair
food allergies
FDA
FDA approves AstraZeneca's Tagrisso-chemo combo
Reuters
Sun, 02/18/24 - 08:26 pm
AstraZeneca
Tagrisso
lung cancer
FDA
FDA’s Marks says CAR-T safety probe ‘probably’ found causal link to lymphoma
Medical Marketing and Media
Fri, 02/16/24 - 11:42 am
CAR-T
FDA
Peter Marks
CBER
FDA to review Sarepta's Duchenne gene therapy for traditional approval
Reuters
Fri, 02/16/24 - 11:38 am
Sarepta Therapeutics
Duchenne Muscular Dystrophy
gene therapy
FDA
Elevidys
FDA fast tracks Diamyd’s immunotherapy for managing type 1 diabetes
Clinical Trials Arena
Thu, 02/15/24 - 07:15 pm
Diamyd
FDA
fast track
type 1 diabetes
Masimo wins first FDA clearance for OTC medical fingertip pulse oximeter
Medtech Dive
Wed, 02/14/24 - 06:34 pm
Masimo
OTC
FDA
Medtech
pulse oximeter
Rocket Pharma gets FDA review extension review of gene therapy
Investing.com
Tue, 02/13/24 - 11:19 pm
Rocket Pharmaceuticals
gene therapy
FDA
Kresladi
Abbott's heart valve repair device gets FDA advisers' backing
Reuters
Tue, 02/13/24 - 11:14 pm
Abbott Labs
Medtech
FDA
TriClip
tricuspid valve regurgitation
With FDA nod for Onivyde combo, Ipsen ends 10-year drought in newly diagnosed pancreatic cancer
Fierce Pharma
Tue, 02/13/24 - 11:12 pm
Ipsen
Onivyde
Nalirifox
pancreatic cancer
FDA
FDA grants orphan drug designation for Disc’s PV treatment
Pharmaceutical Business Review
Mon, 02/12/24 - 11:45 am
Disc Medicine
DISC-3405
polycythemia vera
FDA
FDA fast-tracks GSK’s chronic hep B therapy bepirovirsen
Pharmaphorum
Mon, 02/12/24 - 10:28 am
GSK
FDA
fast track
hepatitis B
bepirovirsen
antisense
FDA approves Takeda's therapy for allergic inflammation in esophagus
Reuters
Mon, 02/12/24 - 10:21 am
Takeda
FDA
Eohilia
eosinophilic esophagitis
FDA repeatedly rejected safety claims made by Philips after the CPAP recall but waited to alert the public, emails show
Medical Marketing and Media
Sun, 02/11/24 - 03:48 pm
Philips
Medtech
FDA
regulatory
recalls
CPAP
FDA staff raises no new concerns about Abbott's heart device
Reuters
Sun, 02/11/24 - 03:45 pm
FDA
Abbott Labs
Medtech
TriClip
tricuspid valve regurgitation

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