FDA

FDA Halts Plan for Vertex, CRISPR Therapeutics Sickle Cell Study
FDA Halts Plan for Vertex, CRISPR Therapeutics Sickle Cell Study
Xconomy
sickle cell disease
FDA
Vertex Pharmaceuticals
CRISPR Therapeutics
CTX001
stem cells
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Celltrion resubmits Rituxan candidate in US, Herceptin version to follow
Celltrion resubmits Rituxan candidate in US, Herceptin version to follow
Biopharma Reporter
Celltrion
Rituxan
biosimilars
FDA
Herceptin
Roche
Biogen
CT-P10
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FDA clears first artificial iris from HumanOptics
FDA clears first artificial iris from HumanOptics
Mass Device
FDA
HumanOptics
CustomFlex
artificial iris
devices
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Breaking Through FDA’s New “Accelerated” Pathway
Breaking Through FDA’s New “Accelerated” Pathway
Medical Devices and Diagnostics Industry
devices
innovation
FDA
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FDA approves TherapeuticsMD's hormone therapy
FDA approves TherapeuticsMD's hormone therapy
Yahoo/Reuters
FDA
TherapeuticsMD
menopause
Imvexxy
vaginal atrophy
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Sage Therapeutics wins priority review for intravenous postpartum depression drug
Sage Therapeutics wins priority review for intravenous postpartum depression drug
Drug Delivery Business News
SAGE Therapeutics
FDA
brexanolone
postpartum depression
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US approves UCB’s Cimzia for psoriasis
US approves UCB’s Cimzia for psoriasis
Pharma Times
FDA
UCB Pharma
Cimzia
psoriasis
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FDA starts speedy review of Loxo’s site-agnostic cancer drug larotrectinib
FDA starts speedy review of Loxo’s site-agnostic cancer drug larotrectinib
Fierce Biotech
FDA
Loxo Oncology
Bayer
metastatic solid tumors
larotrectinib
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FDA Grants Pfizer's Xalkori Breakthrough Therapy Status for Two New Indications
FDA Grants Pfizer's Xalkori Breakthrough Therapy Status for Two New Indications
CP Wire
Pfizer
Xalkori
metastatic non-small cell lung cancer
FDA
breakthrough therapies
anaplastic large-cell lymphoma
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FDA stalls Eisai—and its new partner Merck—in quest to widen cancer med Lenvima's reach
FDA stalls Eisai—and its new partner Merck—in quest to widen cancer med Lenvima's reach
Fierce Pharma
Merck
Eisai
Lenvima
liver cancer
FDA
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BioMarin Rises on Approval of Palynziq (pegvaliase-pqpz)
BioMarin Rises on Approval of Palynziq (pegvaliase-pqpz)
CP Wire
Biomarin
Palynziq
PKU
FDA
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Are small companies carrying the complete response letter can?
Are small companies carrying the complete response letter can?
EP Vantage
FDA
complete response letter
Recro Pharma
Cosmo Pharma
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Look out, J&J. Sun Pharma's Yonsa nod in prostate cancer puts Zytiga on notice
Look out, J&J. Sun Pharma's Yonsa nod in prostate cancer puts Zytiga on notice
Fierce Pharma
JNJ
prostate cancer
Zytiga
Sun Pharma
Yonsa
FDA
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FDA approves Abbott’s latest drug-eluting stent
FDA approves Abbott’s latest drug-eluting stent
Drug Delivery Business News
Abbott Labs
FDA
Xience Sierra everolimus-eluting coronary stent
drug-eluting stents
devices
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A Big Decision Is Fast-Approaching for This Rare-Disease Drugmaker
A Big Decision Is Fast-Approaching for This Rare-Disease Drugmaker
Motley Fool
Biomarin
pegvaliase
PKU
FDA
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FDA demonizes pharma over generics, but most company reputations can take the blow
FDA demonizes pharma over generics, but most company reputations can take the blow
Fierce Pharma
generics
pharma industry
FDA
reputation
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Teva Confirms September PDUFA Date for Fremanezumab
Teva Confirms September PDUFA Date for Fremanezumab
CP Wire
Teva
fremanezumab
migraine
episodic migraines
FDA
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House passes “right-to-try” — allowing the terminally ill to ask companies for experimental drugs outside of FDA’s purview
House passes “right-to-try” — allowing the terminally ill to ask companies for experimental drugs outside of FDA’s purview
Biopharma Dive
right-to-try laws
FDA
Senate
congress
regulatory
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FDA plans to speed path to approval for some gene therapies, starting with hemophilia
FDA plans to speed path to approval for some gene therapies, starting with hemophilia
Stat
FDA
drug approvals
gene therapies
Scott Gottlieb
hemophilia
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Will Amgen’s migraine win and 5th thumbs-up for Prolia drive enough growth? Nope, says analyst
Will Amgen’s migraine win and 5th thumbs-up for Prolia drive enough growth? Nope, says analyst
Fierce Pharma
Amgen
FDA
Aimovig
migraines
Prolia
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