FDA

Eli Lilly, Boehringer Ingelheim's Jardiance clinches heart failure edge with FDA nod for wider label
Fierce Pharma
Fri, 02/25/22 - 10:24 am
Eli Lilly
Boehringer Ingelheim
Jardiance
heart failure
FDA
Go or no go? Bristol’s Lag3 debut
EP Vantage
Fri, 02/25/22 - 10:21 am
Bristol Myers Squibb
relatlimab
FDA
AMX0035
Amylx
Boehringer secures FDA’s Breakthrough Therapy Designation for oral therapy
Pharmaceutical Business Review
Fri, 02/25/22 - 09:58 am
Boehringer Ingelheim
idiopathic pulmonary fibrosis
FDA
BI 1015550
breakthrough status
FDA Approvals Roundup: Pyrukynd and Solosec
RAPS.org
Thu, 02/24/22 - 09:57 am
Agios Pharmaceuticals
Pyrukynds
FDA
Solosec
Lupin
AbbVie sees a megablockbuster in Vraylar. Could a new depression indication push peak sales past $4B?
Endpoints
Wed, 02/23/22 - 10:24 pm
AbbVie
Vraylar
Allergan
major depressive disorder
FDA
FDA’s OPQ 2021 report focuses on pandemic responses
RAPS.org
Wed, 02/23/22 - 10:02 pm
FDA
regulatory
pandemic
OPQ
regulatory inspections
Sanofi and GSK ready to seek authorization for COVID-19 vaccine
Biopharma Reporter
Wed, 02/23/22 - 10:40 am
Sanofi
GSK
vaccines
COVID-19
clinical trials
FDA
FDA slams former CytoDyn CEO's misleading interview in new warning letter
Endpoints
Wed, 02/23/22 - 10:22 am
CytoDyn
FDA
OPDP
leronlimab
COVID-19
AbbVie submits sNDA to FDA for major depressive disorder therapy
Pharmaceutical Business Review
Wed, 02/23/22 - 10:18 am
AbbVie
FDA
cariprazine
major depressive disorder
Tiny pharma hits a new low with FDA refusing to review company's response to its CRL
Endpoints
Tue, 02/22/22 - 10:57 am
Zosano Pharma
FDA
complete response letter
migraines
migraine patch
Another phenylketonuria hold, courtesy of Homology
EP Vantage
Tue, 02/22/22 - 10:43 am
Homology Medicines
HMI-102
Biomarin
BMN 307
FDA
clinical trials
clinical hold
PKU
Medtronic talks diabetes group's FDA warning letter, new products, supply chain constraints
Medtech Dive
Mon, 02/21/22 - 10:40 am
Medtronic
diabetes
FDA
warning letter
devices
Medtech
Agios strategy shift pays off with FDA approval of first drug for rare anemia
MedCity News
Mon, 02/21/22 - 10:28 am
Agios Pharmaceuticals
FDA
pyruvate kinase deficiency
anemia
mitapivat
BioMarin says gene therapy hold will endure as FDA questions cancer risk
BioPharma Dive
Sun, 02/20/22 - 11:54 am
Biomarin
FDA
gene therapy
clinical trials
FDA’s Califf shares priority list with agency staff
RAPS.org
Sun, 02/20/22 - 11:50 am
FDA
regulatory
Robert Califf
pandemic
COVID-19
misinformation
FDA grounds BioMarin gene therapy trial for months with demand for tumor risk data
Fierce Biotech
Fri, 02/18/22 - 10:32 am
Biomarin
FDA
clinical trials
clinical hold
BMN 307
PKU
gene therapy
AbbVie Snags FDA Approval for Another Indication. Will It Become Another Blockbuster?
Motley Fool
Fri, 02/18/22 - 10:30 am
AbbVie
Skyrizi
FDA
psoriatic arthritis
This Week at FDA: QSR meeting, Woodcock’s new role, and more
RAPS.org
Fri, 02/18/22 - 10:29 am
FDA
regulatory
QSR
devices
Janet Woodcock
Robert Califf
FDA updates Merck's Covid-19 pill EUA and reaffirms it should only be used as a last resort
Endpoints
Fri, 02/18/22 - 10:25 am
Merck
molnupiravir
FDA
Pfizer
COVID-19
antivirals
Paxlovid
Agios wins FDA approval for drug to treat rare form of anemia
Stat
Thu, 02/17/22 - 11:16 pm
Agios
mitapivat
pyruvate kinase deficiency
anemia
FDA

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