FDA

FY22 Drug Recalls Highest in Five Years: FDA Report
BioSpace
Thu, 06/22/23 - 10:16 am
FDA
drug manufacturing
product recalls
regulatory
Pfizer's Talzenna snags broader prostate cancer nod than AstraZeneca and Merck's rival PARP med
Fierce Pharma
Thu, 06/22/23 - 10:12 am
Pfizer
FDA
prostate cancer
Talzenna
AstraZeneca
PARP inhibitors
Merck
Amgen granted full FDA approval for blood cancer treatment
Biopharma Reporter
Thu, 06/22/23 - 10:10 am
Amgen
Blincyto
FDA
blood cancer
Aldeyra Therapeutics reports that FDA rejects eye cancer drug
Benzinga
Wed, 06/21/23 - 10:56 pm
Aldeyra Therapeutics
FDA
eye cancer
ADX-2191
Bluebird, playing catch-up, gets decision date for sickle cell gene therapy
BioPharma Dive
Wed, 06/21/23 - 11:49 am
Bluebird Bio
gene therapy
sickle cell disease
lovo-cel
FDA
Why drug shortages might worsen
Beckers Hospital Review
Wed, 06/21/23 - 10:56 am
FDA
India
drug shortages
drug manufacturing
FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes
Benzinga
Tue, 06/20/23 - 09:46 pm
Eli Lilly
Boehringer Ingelheim
Jardiance
Synjardy
type 2 diabetes
pediatric
FDA
Agepha Pharma gets ancient gout remedy colchicine across FDA finish line for heart disease
Fierce Pharma
Tue, 06/20/23 - 09:35 pm
Agepha Pharma
FDA
colchicine
heart disease
Lodoco
FDA places clinical hold on Arcellx’s multiple myeloma therapy trial
Clinical Trials Arena
Tue, 06/20/23 - 09:57 am
Arcellx
CAR-T
CART-ddBCMA
relapsed or refractory multiple myeloma
FDA
clinical trials
AbbVie's Skyrizi posts ulcerative colitis win in maintenance study, teeing up FDA nod
Fierce Pharma
Fri, 06/16/23 - 10:12 am
AbbVie
ulcerative colitis
Skyrizi
FDA
On the Cusp of Full Approval, Leqembi’s Rollout Could Face Challenges
BioSpace
Fri, 06/16/23 - 10:01 am
Eisai
Biogen
Alzheimer's disease
FDA
Leqembi
After Adcomm’s Vaccine Recommendation, Can Novavax Make a Covid Comeback?
BioSpace
Fri, 06/16/23 - 10:00 am
FDA
COVID-19
vaccines
Novavax
Roche follows AbbVie with FDA approval for dual-targeting lymphoma drug
BioPharma Dive
Fri, 06/16/23 - 09:57 am
Roche
Columvi
FDA
relapsed or refractory diffuse large B-cell lymphoma
blood cancer
FDA delays approval decision on GSK's $1.9B blood cancer bet
Fierce Biotech
Fri, 06/16/23 - 09:52 am
GSK
FDA
momelotinib
blood cancer
FDA approves Biostar’s Phase II/III plans with utidelone injectable for NSCLC
Clinical Trials Arena
Fri, 06/16/23 - 09:50 am
Biostar
FDA
utidelone
UTD1
non-small cell lung cancer
FDA Puts Mersana’s Ovarian Cancer Trials on Partial Clinical Hold
BioSpace
Thu, 06/15/23 - 06:58 pm
Mersana Therapeutics
clinical trials
FDA
ovarian cancer upifitamab rilsodotin
antibody-drug conjugate
Smith+Nephew Nabs 510(k) Clearance for AETOS Shoulder System
Medical Devices and Diagnostics Industry
Wed, 06/14/23 - 06:37 pm
Medtech
Smith & Nephew
FDA
AETOS Shoulder System
reverse shoulder replacement
Pfizer and GSK to battle for share of new RSV vaccine market
Biopharma Reporter
Wed, 06/14/23 - 11:33 am
Pfizer
GSK
FDA
vaccines
RSV
Awaiting FDA hold letter, PepGen accepts 2nd oligonucleotide is no closer to clinic
Fierce Biotech
Wed, 06/14/23 - 11:30 am
PepGen
oligonucleotide
FDA
myotonic muscular dystrophy
PGN-EDODM1
After Albireo buyout, Ipsen's Bylvay picks up new FDA-approved use
Fierce Pharma
Wed, 06/14/23 - 10:22 am
Ipsen
Bylvay
Albireo Pharma
M&A
FDA
liver disease

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