FDA

Novartis Calls for FDA Enforcement Against Biosimilar Misinformation
Novartis Calls for FDA Enforcement Against Biosimilar Misinformation
RAPS.org
Novartis
FDA
biosimilars
citizen petitions
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AbbVie's Orilissa makes its uterine fibroids case with double phase 3 win
AbbVie's Orilissa makes its uterine fibroids case with double phase 3 win
Fierce Pharma
AbbVie
Orilissa
FDA
uterine fibroids
Neurocrine
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Lilly's third-to-market Emgality nets FDA 'breakthrough' in cluster headache
Lilly's third-to-market Emgality nets FDA 'breakthrough' in cluster headache
Fierce Pharma
Eli Lilly
Emgality
cluster headaches
FDA
breakthrough therapies
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FDA warns on pain drugs for implantable pumps
FDA warns on pain drugs for implantable pumps
Drug Delivery Business News
FDA
implantable drug pump
painkillers
devices
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Biotech Eli Lilly files for FDA approval of migraine drug lasmiditan
Biotech Eli Lilly files for FDA approval of migraine drug lasmiditan
Fierce Biotech
Eli Lilly
migraines
FDA
Lasmiditan
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What's coming? Pazdur, Marks and Woodcock discuss FDA changes
What's coming? Pazdur, Marks and Woodcock discuss FDA changes
Endpoints
FDA
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FDA Proposes Changes to Informed Consent Rules
FDA Proposes Changes to Informed Consent Rules
RAPS.org
FDA
clinical trials
informed consent
IRBs
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Roche’s Tecentriq gets fast review in triple negative breast cancer
Roche’s Tecentriq gets fast review in triple negative breast cancer
Pharmaforum
Roche
Genentech
Tecentriq
Celgene
Abraxane
FDA
triple negative breast cancer
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FDA Grants Breakthrough Therapy Designation to First Oral Drug for Suicidal Bipolar Depression
FDA Grants Breakthrough Therapy Designation to First Oral Drug for Suicidal Bipolar Depression
CP Wire
NRX-101
NeuroRx
FDA
bipolar disorder
breakthrough therapies
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FDA Hits Monthly Generic Drug Approval Record in October
FDA Hits Monthly Generic Drug Approval Record in October
RAPS.org
FDA
drug approvals
generics
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Mylan, Theravance win FDA approval for COPD drug
Mylan, Theravance win FDA approval for COPD drug
Biopharma Dive
Theravance
Mylan
Yupelri
COPD
FDA
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FDA Accepts sNDA for Lynparza for Maintenance Therapy in Advanced Ovarian Cancer and Grants Priority Review
FDA Accepts sNDA for Lynparza for Maintenance Therapy in Advanced Ovarian Cancer and Grants Priority Review
CP Wire
Lynparza
Merck
AstraZeneca
ovarian cancer
FDA
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Merck gets FDA okay for Keytruda as liver cancer therapy
Merck gets FDA okay for Keytruda as liver cancer therapy
Pharmaforum
Merck
Keytruda
FDA
hepatocellular carcinoma
liver cancer
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FDA Action Alert: Theravance, Mallinckrodt and Aquestive
FDA Action Alert: Theravance, Mallinckrodt and Aquestive
BioSpace
FDA
Theravance
revefenacin
COPD
Mallinckrodt
MNK-812
Aquestive Therapeutics
AQST-199
erectile dysfunction
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Gottlieb highlights changes to improve expanded access program
Gottlieb highlights changes to improve expanded access program
BioCentury
FDA
Scott Gottlieb
expanded access programs
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Bristol-Myers Squibb snags quick Empliciti combo nod in multiple myeloma
Bristol-Myers Squibb snags quick Empliciti combo nod in multiple myeloma
Fierce Pharma
Bristol-Myers Squibb
AbbVie
Empliciti
FDA
Multiple Myeloma
Celgene
Pomalyst
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Drugmakers Seek Clarity on Guidance on Use of Placebo and Blinding in Oncology Trials
Drugmakers Seek Clarity on Guidance on Use of Placebo and Blinding in Oncology Trials
RAPS.org
oncology
FDA
clinical trials
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5 election takeaways for pharma
5 election takeaways for pharma
Biopharma Dive
elections
drug pricing
Donald Trump
Medicaid
FDA
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Sage depression drug to cost between $20K and $35K, if approved
Sage depression drug to cost between $20K and $35K, if approved
Biopharma Dive
SAGE Therapeutics
Zulresso
postpartum depression
FDA
drug pricing
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FDA Approves Elanco Cattle Drug, the First for Reducing Gas Emissions
FDA Approves Elanco Cattle Drug, the First for Reducing Gas Emissions
Xconomy
Elanco
FDA
Experior
farm waste emissions
animal health
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