FDA

US Generic Drug Approvals Tick Upward in March and April
US Generic Drug Approvals Tick Upward in March and April
RAPS.org
generics
FDA
drug approvals
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FDA Approves First in Class TAVALISSE for Chronic Immune Thrombocytopenia (ITP) in Adults
FDA Approves First in Class TAVALISSE for Chronic Immune Thrombocytopenia (ITP) in Adults
CP Wire
Rigel Pharmaceuticals
Tavalisse
chronic immune thrombocytopenia
FDA
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GW Pharma riding high as cannabinoid Epidiolex nears first U.S. approval
GW Pharma riding high as cannabinoid Epidiolex nears first U.S. approval
Fierce Biotech
GW Pharma
Epidiolex
FDA
epilepsy
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FDA chief Scott Gottlieb promises to streamline drug development pathway for biopharma
FDA chief Scott Gottlieb promises to streamline drug development pathway for biopharma
Endpoints
FDA
Scott Gottlieb
drug development
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After FDA Approves Bone Disease Drug, Ultragenyx Sets $200K Price
After FDA Approves Bone Disease Drug, Ultragenyx Sets $200K Price
Xconomy
Ultragenyx
FDA
X-linked hypophosphatemia
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FDA releases new action plan looking to improve device cybersecurity, streamline approvals
FDA releases new action plan looking to improve device cybersecurity, streamline approvals
Mass Device
FDA
devices
regulatory
cybersecurity
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Roche gets double dose of good Hemlibra news with FDA breakthrough, ICER backing
Roche gets double dose of good Hemlibra news with FDA breakthrough, ICER backing
Fierce Pharma
Roche
Hemlibra
hemophilia
FDA
breakthrough status
ICER
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FDA Now Accepts Alkermes Application It Rejected Two Weeks Ago
FDA Now Accepts Alkermes Application It Rejected Two Weeks Ago
CP Wire
Alkermes
ALKS-5461
major depressive disorder
FDA
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FDA relaxes clinical hold on Translate Bio’s cystic fibrosis drug
FDA relaxes clinical hold on Translate Bio’s cystic fibrosis drug
Fierce Biotech
Translate Bio
clinical trials
MRT5005
FDA
cystic fibrosis
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Next-generation sequencing: FDA offers guidance to streamline path to market
Next-generation sequencing: FDA offers guidance to streamline path to market
Endpoints
FDA
gene sequencing
IVDs
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Novartis CEO: How To Create Cheaper Alternatives To The Most Expensive Drugs
Novartis CEO: How To Create Cheaper Alternatives To The Most Expensive Drugs
Forbes
Novartis
Pharma CEOs
FDA
drug pricing
Vasant Narasimham
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Does the FDA’s ‘breakthrough’ drug program need to be reformed? Harvard skeptics say yes
Does the FDA’s ‘breakthrough’ drug program need to be reformed? Harvard skeptics say yes
Endpoints
FDA
Harvard
breakthrough status
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Bellicum Shares Up After Clinical Hold lifted on BPX-501
Bellicum Shares Up After Clinical Hold lifted on BPX-501
CP Wire
Bellicum
BPX-501
FDA
clinical trials
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FDA’s Role in the New Era of Medtech Collaboration
FDA’s Role in the New Era of Medtech Collaboration
Medical Devices and Diagnostics Industry
devices
value-based care
risk-sharing contracts
FDA
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FDA approves first AI-powered device to detect diabetic retinopathy
FDA approves first AI-powered device to detect diabetic retinopathy
Drug Delivery Business News
artificial intelligence
devices
diabetic retinopathy
FDA
IDx
IDx-DR
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After yet another PhIII Alzheimer’s failure, experts try to map a path out of the wrecking field
After yet another PhIII Alzheimer’s failure, experts try to map a path out of the wrecking field
Endpoints
FDA
Alzheimer's disease
R&D
NIH
biomarkers
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FDA Requires More Time to Review Abbvie and Neurocrine Endometriosis Drug Elagolix
FDA Requires More Time to Review Abbvie and Neurocrine Endometriosis Drug Elagolix
CP Wire
AbbVie
Neurocrine
FDA
Elagolix
endometriosis
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FDA to Launch a National Registry for Implantable Cardiac Defibrillators
FDA to Launch a National Registry for Implantable Cardiac Defibrillators
RAPS.org
FDA
implantable cardiac defibrillators
devices
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FDA Wants to Know What Prevents Exposure-Response Analyses in Drug Development
FDA Wants to Know What Prevents Exposure-Response Analyses in Drug Development
RAPS.org
FDA
exposure-response analyses
drug development
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FDA Says Tenax Therapeutics Can Submit Levosimendan Ph II Protocol for Pulmonary Hypertension Under Existing IND
FDA Says Tenax Therapeutics Can Submit Levosimendan Ph II Protocol for Pulmonary Hypertension Under Existing IND
CP Wire
Tenax Therapeutics
levosimendan
clinical trials
FDA
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