The latest news from the global pharmaceutical industry. Below you will find news and information to keep you up-to-date with what is happening in your industry. Coverage includes regulatory approvals, recall announcements, mergers and acquisitions, personnel news and appointments, new facility and facility expansion updates, collaborations and agreements, and financial updates.
Taiho Oncology announced the FDA has accepted and granted priority review for the sNDA for Lonsurf.
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The FDA approved Xyrem (sodium oxybate) for the treatment of cataplexy and excessive daytime sleepiness (EDS) in pediatric patients (7 to 17 years old...
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Thursday, November 01, 2018
BioSpecifics Technologies announced positive topline data from its Phase 1 trial of Collagenase Clostridium Histolyticum (CCH) for the treatment of ...
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Friday, November 02, 2018
Alkermes Reports on Outcome of FDA Advisory Committee Meeting on ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder.
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Monday, November 05, 2018
AcelRx Pharmaceuticals announced the approval of Dsuvia by the FDA.
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Thursday, November 08, 2018
Visterra announced the initiation of a Phase 1 clinical study with VIS649 in healthy volunteers.
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Tuesday, November 20, 2018
The FDA expanded the approved use of Adcetris injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell ...
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Wednesday, November 21, 2018
Daiichi Sankyo announced the FDA has accepted a NDA and granted Priority Review for quizartinib for the treatment of adult patients with relapsed/...
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Monday, November 26, 2018
CURE has secured a new registration with the Drug Enforcement Administration (DEA) as a manufacturer authorized to handle Schedule 1 controlled ...
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Monday, December 03, 2018
Amgen and UCB announced the FDA BRUDAC will review data supporting the BLA for Evenity for the osteoporosis in postmenopausal women at high risk for ...
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Tuesday, December 04, 2018
Alkahest announced dosing of the first subject in a trial of its human plasma fraction, GRF6021, for the treatment of Parkinson's disease with ...
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Monday, December 10, 2018
Vanda announced Hetlioz (tasimelteon) improved sleep quality and increased sleep duration in patients with Smith-Magenis Syndrome (SMS) in a pivotal ...
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Tuesday, December 11, 2018
As we continue to implement our 2018 Compounding Priorities Plan, our mission is to preserve patient access to compounded drugs to meet patients’ ...
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Wednesday, December 19, 2018
The European Commission has granted marketing authorization for Dengvaxia, Sanofi's dengue vaccine.
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Friday, December 21, 2018
Oxford BioTherapeutics has received IND clearance from the FDA for OBT076, an experimental ADC for the treatment of women with high risk HER2 negative...
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