FDA

Regeneron announces FDA acceptance for sBLA review of Libtayo with chemotherapy for NSCLC
Pharmaceutical Business Review
Thu, 01/20/22 - 11:00 am
Regeneron
FDA
Libtayo
non-small cell lung cancer
Secondary patents prove to be key in biosimilar blocking strategies, researchers find
Endpoints
Wed, 01/19/22 - 11:21 pm
FDA
biosimilars
patents
secondary patents
FDA misses MDUFA V deadline after months of contentious talks
Medtech Dive
Wed, 01/19/22 - 11:17 pm
FDA
devices
MDUFA
MDUVA V
regulatory
Pfizer Covid Vaccine For Kids Under 5 Could Be Authorized In The Next Month, Fauci Says
Forbes
Wed, 01/19/22 - 11:14 pm
Pfizer
BioNTech
COVID-19
vaccines
Anthony Fauci
FDA
FDA has no appetite for Levo’s metabolic disorder drug and asks for new trial
MedCity News
Wed, 01/19/22 - 11:11 am
Levo Therapeutics
Prader-Willi Syndrome
FDA
LV-101
Califf previews priorities if confirmed as FDA commissioner
RAPS.org
Tue, 01/18/22 - 11:52 pm
FDA
Robert Califf
Inside the Catalent FDA citation said to trigger Novo Nordisk's Wegovy supply hiccup
Fierce Pharma
Tue, 01/18/22 - 10:49 am
Catalent
FDA
Novo Nordisk
Wegovy
supply chain
No stranger to headwinds, bluebird runs into two PDUFA delays unrelated to new safety issues
Endpoints
Tue, 01/18/22 - 10:40 am
Bluebird Bio
beti-cel
eli-cel
FDA
gene therapy
beta thalassemia
With few remaining unapproved drugs, researchers tell FDA its Unapproved Drugs Initiative is no longer effective
Endpoints
Tue, 01/18/22 - 10:26 am
FDA
Unapproved Drugs Initiative
FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care
FDA Law Blog
Tue, 01/18/22 - 10:23 am
FDA
regulatory
3D printing
devices
Medtech
U.S. would seek global approach to updating Covid-19 vaccines, official says
Stat
Tue, 01/18/22 - 10:22 am
FDA
COVID-19
vaccines
Omicron COVID-19 variant
COVID-19 variants
Former commissioners, Woodcock dissect pandemic response, future challenges at FDA
RAPS.org
Tue, 01/18/22 - 10:18 am
FDA
Janet Woodcock
pandemic
COVID-19
regulatory
Abbott’s New Cardiac Mapping System Gets FDA Clearance for Treatment of Cardiac Arrhythmias
Xtalks
Mon, 01/17/22 - 10:39 am
Abbott Labs
cardiac mapping ENSite X EP
FDA
cardiac arrhythmias
Pfizer's Cibinqo snags FDA approval to challenge Sanofi and Regeneron's Dupixent in eczema
Fierce Pharma
Sun, 01/16/22 - 03:53 am
Pfizer
Sanofi
Regeneron
FDA
Cibinqo
atopic dermatitis
FDA approval, global partnership on the agenda at Mithra as phase 3 menopause trials hit goals—with one blemish
Fierce Biotech
Fri, 01/14/22 - 11:18 am
Mithra
clinical trials
menopause
FDA
hot flashes
Senate committee advances Califf’s nomination as FDA commissioner
RAPS.org
Thu, 01/13/22 - 10:27 pm
FDA
Robert Califf
Senate
5 questions facing gene therapy in 2022
BioPharma Dive
Thu, 01/13/22 - 10:21 pm
gene therapy
funding
FDA
FDA denies Denali's Takeda-partnered Alzheimer's drug from entering clinic
Fierce Biotech
Thu, 01/13/22 - 10:19 pm
Denali Therapeutics
Takeda
Alzheimer's disease
FDA
DNL919
7 drugs likely to hit $1B in annual revenue in the next 5 years
Beckers Hospital Review
Thu, 01/13/22 - 07:31 am
FDA
adagrasib
donanemab
faricimab
lecanemab
tezepelumab
tirzepatide
vutrisiran
Eli Lilly
Mirati Therapeutics
Roche
Chugai
Eisai
Biogen
AstraZeneca
Amgen
Alnylam
FDA adds rare bleeding risk to J&J shot side effects
Beckers Hospital Review
Thu, 01/13/22 - 07:26 am
FDA
vaccines
JNJ
chronic immune thrombocytopenia
COVID-19

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