FDA

Gout Disease Control Suffered After FDA-Driven Price Hike: Study
BioSpace
Thu, 05/11/23 - 10:01 am
FDA
gout
colchicine
drug pricing
Takeda
Colcrys
Immunitybio slumps as FDA declines to approve bladder cancer treatment
NASDAQ
Thu, 05/11/23 - 09:58 am
ImmunityBio
FDA
bladder cancer
anktiva
Perrigo's OTC birth control pill aces FDA expert meeting
Fierce Pharma
Wed, 05/10/23 - 11:14 pm
Perrigo
Opill
FDA
OTC contraceptive pill
FDA reviewers flag concerns over Sarepta's gene therapy for DMD
Yahoo/Reuters
Wed, 05/10/23 - 10:08 am
Sarepta Therapeutics
FDA
DMD
Duchenne Muscular Dystrophy
gene therapy
Samsung gets FDA clearance for irregular heart notification feature, catching up with Apple and Fitbit
Medtech Dive
Tue, 05/9/23 - 11:35 pm
Samsung
FDA
Medtech
atrial fibrillation
Farxiga Approval Expands Use to More Patients With Heart Failure
eMPR
Tue, 05/9/23 - 11:28 pm
AstraZeneca
Farxiga
FDA
FDA Accepts Application for Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)
BioSpace
Tue, 05/9/23 - 12:27 pm
Roche
Genentech
FDA
Vabysmo
macular edema
retinal vein occlusion
Cut Short by RSV: GSK’s compelling ad ties into recent FDA approval
Medical Marketing and Media
Mon, 05/8/23 - 11:32 pm
GSK
RSV
vaccines
DTC ads
FDA
FDA, weighing Perrigo's OTC birth control application, raises questions about real-world use
Fierce Pharma
Mon, 05/8/23 - 10:10 am
Perrigo
FDA
Opill
OTC contraceptive pill
After FDA rejection, Gilead nears full EU nod for hep D drug
Pharmaphorum
Fri, 05/5/23 - 11:15 am
Gilead Sciences
hepatitis D
FDA
Europe
Hepcludex
buleviritide
FDA approves first RSV vaccine, clearing GSK’s Arexvy for older adults
BioPharma Dive
Wed, 05/3/23 - 10:49 pm
GSK
RSV
vaccines
Arexvy
FDA
FDA encourages decentralized trials with new guidance
Fierce Biotech
Wed, 05/3/23 - 11:50 am
FDA
clinical trials
decentralized clinical trials
Gene Therapies Are Still Hampered By Substantial Delays Between Approval And Launch
Forbes
Wed, 05/3/23 - 11:48 am
gene therapy
drug approvals
Biomarin
Bluebird Bio
FDA
Sarepta, days out from critical FDA meeting, lists questions expected at gene therapy AdComm
Fierce Biotech
Wed, 05/3/23 - 11:39 am
Sarepta Therapeutics
FDA
SRP-9001
DMD
Duchenne Muscular Dystrophy
Sun's Concert hits bum note as FDA imposes partial hold 2 months after $576M buyout
Fierce Biotech
Tue, 05/2/23 - 10:19 am
Sun Pharma
Concerta Pharmaceuticals
M&A
FDA
Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy
Fierce Pharma
Mon, 05/1/23 - 10:11 pm
Teva Pharmaceutical
MedinCell
FDA
schizophrenia
Uzedy
Risperidone
FDA Accepts sBLA of BMS' Reblozyl
Targeted Oncology
Mon, 05/1/23 - 10:01 pm
Bristol Myers Squibb
Reblozyl
FDA
MDS
anemia
Allogeneic cell therapy approval to pave the way for future therapies in this class
Clinical Trials Arena
Mon, 05/1/23 - 10:05 am
Gamida Cell
stem cell transplant
Omisirge
blood cancer
FDA
Otsuka, Lundbeck gain FDA nod for longer-acting version of schizophrenia drug Abilify
Fierce Pharma
Mon, 05/1/23 - 10:04 am
Otsuka
Lundbeck
FDA
Abilify
Asimtufii
bipolar disorder
FDA sent letter to HCPs warning of cybersecurity risk in Illumina sequencing software
FDA
Fri, 04/28/23 - 10:36 am
Illumina
sequencing
FDA
cybersecurity

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