FDA

ASCO: J&J, AbbVie go back to Imbruvica's roots in lymphoma. Will lack of survival win matter?
Fierce Pharma
Fri, 06/3/22 - 10:27 am
AbbVie
JNJ
ASCO 2022
FDA
Imbruvica
MCL
Pfizer completes COVID-19 vaccine application for kids under 5
Beckers Hospital Review
Thu, 06/2/22 - 07:27 pm
Pfizer
vaccines
FDA
COVID-19
pediatric
Another refuse-to-file for a small biotech — is the FDA using RTFs to manage its workload?
Endpoints
Thu, 06/2/22 - 07:24 pm
FDA
Aeglea BioTherapeutics
pegzilarginase
After filing for bankruptcy, rejected migraine drug developer Zosano’s value more than halved
Endpoints
Thu, 06/2/22 - 12:14 pm
Zosano Pharma
migraines
layoffs
FDA
Even at $2M+, ICER calls bluebird's potential gene therapy for blood disorder 'superior' to standard of care
Endpoints
Thu, 06/2/22 - 10:22 am
Bluebird Bio
ICER
gene therapy
FDA
beti-cel
Novartis' surprise radiotherapy production halt nearing an end as FDA docs shed light on plant woes
Fierce Pharma
Thu, 06/2/22 - 10:20 am
Novartis
radiotherapy
FDA
Lutathera
Pluvicto
Regeneron's cholesterol drug war heats up with lawsuit over Amgen's 'illegal' bundling scheme
Fierce Pharma
Wed, 06/1/22 - 07:36 pm
Regeneron
Amgen
FDA
antitrust
legal
Repatha
Praluent
Sage, Biogen drug meets goal in postpartum depression study
BioPharma Dive
Wed, 06/1/22 - 07:32 pm
SAGE Therapeutics
Biogen
FDA
zuranolone
postpartum depression
FDA clarifies rules around drug importation from Canada
Beckers Hospital Review
Wed, 06/1/22 - 09:51 am
FDA
regulatory
Canada
drug importation
Sanofi: FDA Grants Efanesoctocog Alfa Breakthrough Therapy Designation For Hemophilia A
NASDAQ
Wed, 06/1/22 - 09:35 am
Sanofi
FDA
breakthrough designation
hemophilia A
efanesoctocog alfa
Will third time be the charm? Lexicon finally refiles SGLT2 drug for heart failure
Endpoints
Tue, 05/31/22 - 11:58 pm
Lexicon Pharmaceuticals
sotagliflozin
heart failure
FDA
BioMarin Delays Hemophilia A Therapy Filing as FDA Calls for More Data
BioSpace
Tue, 05/31/22 - 11:57 pm
Biomarin
hemophilia A
FDA
valoctocogene roxaparvovec
Study: Breakthrough designated drugs led to better clinical outcomes for patients with NSCLC
RAPS.org
Tue, 05/31/22 - 11:54 pm
FDA
breakthrough designation
non-small cell lung cancer
FDA grants speedy review to Dupixent rare skin disease
Pharmaforum
Tue, 05/31/22 - 10:43 am
Sanofi
Regeneron
Dupixent
prurigo nodularis
FDA
Novartis (NVS) Wins FDA Nod for Label Expansion of Kymriah
Yahoo/Zacks.com
Tue, 05/31/22 - 10:41 am
Novartis
FDA
Kymriah
CAR-T
relapsed or refractory follicular lymphoma
Roche puts pressure on SMA rivals with new FDA approval
Pharmaforum
Tue, 05/31/22 - 10:33 am
Roche
PTC Therapeutics
SMA
Evrysdi
FDA
Amneal scores third biosimilar approval in three months
Biopharma Reporter
Tue, 05/31/22 - 10:31 am
Amneal
FDA
biosimilars
pegfilgrastim
Fylnetra
Amgen
Neulasta
Go or no go? The FDA’s Amylyx dilemma
EP Vantage
Tue, 05/31/22 - 10:29 am
FDA
Amylyx
AMX0035
ALS
COVID-19
vaccines
Novavax
Moderna Therapeutics
Pfizer
Acadia Pharma
Bluebird Bio
Pfizer (PFE) Gets Fast Track Designation for NASH Therapy
Yahoo/Zacks.com
Mon, 05/30/22 - 10:25 am
Pfizer
NASH
FDA
fast track
ervogastat/clesacostat
Here's What AstraZeneca's Recent FDA News Means for Shareholders
Motley Fool
Mon, 05/30/22 - 10:15 am
AstraZeneca
FDA
Imfinzi
tremelimumab
liver cancer

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