FDA

Big Week Ahead for Eli Lilly: Here's What to Look For
Big Week Ahead for Eli Lilly: Here's What to Look For
Motley Fool
Eli Lilly
earnings
FDA
Incyte
olumiant
rheumatoid arthritis
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Interview With Gottlieb: A Discussion on Biosimilars, Opioids and Transparency
Interview With Gottlieb: A Discussion on Biosimilars, Opioids and Transparency
RAPS.org
FDA
Scott Gottlieb
biosimilars
generics
opioids
transparency
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FDA Details Policies for Study Datasets in Vaccine Trials
FDA Details Policies for Study Datasets in Vaccine Trials
RAPS.org
FDA
vaccines
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Helsinn Group Announces FDA approval of IV Formulation of Akynzeo for Chemotherapy Induced Nausea and Vomiting Configure
Helsinn Group Announces FDA approval of IV Formulation of Akynzeo for Chemotherapy Induced Nausea and Vomiting Configure
CP Wire
Helsinn Group
FDA
Akynezo
chemotherapy-induced nausea and vomiting
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FDA Panel Votes To Approve Marijuana-Based Drug For Epilepsy
FDA Panel Votes To Approve Marijuana-Based Drug For Epilepsy
Forbes
FDA
GW Pharma
Epidiolex
epilepsy
advisory panels
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FDA Approves IND for OBI Pharma's OBI-3424 for a Ph I/II Study in AKR1C3 Solid Tumors
FDA Approves IND for OBI Pharma's OBI-3424 for a Ph I/II Study in AKR1C3 Solid Tumors
CP Wire
OBI Pharma
FDA
OBI-3424
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Will Ilumya Kill Valeant's Psoriasis Dreams?
Will Ilumya Kill Valeant's Psoriasis Dreams?
Seeking Alpha
Sun Pharma
Ilumya
FDA
psoriasis
Siliq
Valeant Pharmaceuticals
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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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