FDA

Incyte's cash cow Jakafi chugs along with positive frontline results for GVHD
Incyte's cash cow Jakafi chugs along with positive frontline results for GVHD
Endpoints
Incyte
FDA
graft vs host disease
Jakafi
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FDA Approves Noven Pharmaceuticals’ Transdermal Patch for Schizophrenia
FDA Approves Noven Pharmaceuticals’ Transdermal Patch for Schizophrenia
BioSpace
Secuado
Noven Pharmaceuticals
FDA
schizophrenia
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FDA Addresses Questions on 510(k) Third-Party Review Program
FDA Addresses Questions on 510(k) Third-Party Review Program
RAPS.org
FDA
devices
third-party review
medical device user fee act
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Canada's Decision To Make Public More Clinical Trial Data Puts Pressure On FDA
Canada's Decision To Make Public More Clinical Trial Data Puts Pressure On FDA
NPR
Canada
FDA
clinical trial data
clinical trial
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In-house FDA review flags a suspicious imbalance in deaths as Shionogi hunts an OK for antibiotic
In-house FDA review flags a suspicious imbalance in deaths as Shionogi hunts an OK for antibiotic
Endpoints
Shionogi
FDA
advisory panels
antibiotics
UTIs
cefiderocol
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FDA OKs new use for J&J's Xarelto
FDA OKs new use for J&J's Xarelto
Seeking Alpha
JNJ
Xarelto
venous thromboembolism
FDA
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Why Amarin Investors Have Their Eyes on Nov. 14
Why Amarin Investors Have Their Eyes on Nov. 14
Motley Fool
Amarin
Vascepa
FDA
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2 Biotechs With Approaching Drug Approvals
2 Biotechs With Approaching Drug Approvals
Motley Fool
drug approvals
drug launches
FDA
voxelotor
Global Blood Therapeutics
Immunomedics
sacituzumab govitecan
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FDA OKs Lilly’s Lasmiditan, First New Acute Migraine Drug in Decades
FDA OKs Lilly’s Lasmiditan, First New Acute Migraine Drug in Decades
Xconomy
Eli Lilly
migraines
Lasmiditan
FDA
Reyvow
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Have FDA’s Generic Approvals Helped With Competition? Researchers Say Too Early to Tell
Have FDA’s Generic Approvals Helped With Competition? Researchers Say Too Early to Tell
RAPS.org
FDA
generics
competition
drug approvals
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Drugmakers could avoid paying rebates under new FDA guidance
Drugmakers could avoid paying rebates under new FDA guidance
Beckers Hospital Review
FDA
rebates
PBMs
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Australian drugmaker's decade-long journey ends in FDA approval
Australian drugmaker's decade-long journey ends in FDA approval
Biopharma Dive
Clinuvel
FDA
Australia
erythropoietic protoporphyria
Scenesse
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Shionogi celebrates antibiotic win in pneumonia just ahead of its date with FDA regulators
Shionogi celebrates antibiotic win in pneumonia just ahead of its date with FDA regulators
Endpoints
Shionogi
antibiotics
FDA
cefiderocol
nosocomial pneumonia
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FDA Issues Draft Guidance on Expanded Conditional Approval for Animal Drugs
FDA Issues Draft Guidance on Expanded Conditional Approval for Animal Drugs
FDA Law Blog
FDA
animal health
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Rare Disease Clinical Trials: FDA Awards $15M in Grants
Rare Disease Clinical Trials: FDA Awards $15M in Grants
RAPS.org
grants
clinical trials
FDA
Rare Diseases
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FDA leaders worry agency will lose out on talent in gene therapy, cancer fields
FDA leaders worry agency will lose out on talent in gene therapy, cancer fields
Biopharma Dive
FDA
gene therapy
oncology
cell therapy
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Novartis’ new eye drug undercuts Bayer’s rival with fewer injections
Novartis’ new eye drug undercuts Bayer’s rival with fewer injections
Pharmaforum
Novartis
brolucizumab
Bayer
Eylea
wet age-related macular degeneration
FDA
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Public Citizen urges FDA to ‘immediately’ withdraw drug for preventing premature birth
Public Citizen urges FDA to ‘immediately’ withdraw drug for preventing premature birth
Stat
Makena
premature birth
Amag Pharmaceuticals
FDA
citizen petitions
Public Citizen
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Is FDA Becoming Too Lax With its Drug Approval Standards? Senior FDA Officials Discuss
Is FDA Becoming Too Lax With its Drug Approval Standards? Senior FDA Officials Discuss
RAPS.org
FDA
drug approvals
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Novartis' latest Zolgensma data bode well for use in older patients
Novartis' latest Zolgensma data bode well for use in older patients
Fierce Pharma
Novartis
Zolgensma
SMA
FDA
spinal muscular atrophy
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