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.
Thursday, November 21, 2019
Seelos announced the FDA has granted Fast Track designation to its new intranasal racemic ketamine program for the treatment of Acute Suicidal ...
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Friday, November 22, 2019
The FDA approved XCOPRI (cenobamate tablets) to treat partial-onset seizures in adults.
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Monday, November 25, 2019
Orchard Therapeutics announced the CHMP of the EMA has granted an accelerated assessment for OTL-200 for the treatment of metachromatic leukodystrophy...
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Monday, November 25, 2019
The FDA has authorized the advancement of Plenitude, the company’s clinical trial for its investigational therapeutic QIXLEEF for uncontrolled pain in...
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Monday, November 25, 2019
Mitsubishi Tanabe Pharma America announced the initiation of a global Phase 3 study evaluating an investigational oral suspension formulation of ...
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Tuesday, November 26, 2019
Phoenix Molecular Designs has dosed the first patient in its Phase 1/1b study of PMD-026, the company's lead product candidate.
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Tuesday, November 26, 2019
The FDA granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease in adults and pediatric patients 12 years of age ...
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Wednesday, November 27, 2019
The China NMPA approved a NDA for XTANDI® (enzalutamide) for adult men with metastatic castration-resistant prostate cancer.
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Wednesday, November 27, 2019
Usona Institute has received Breakthrough Therapy Designation from the FDA for psilocybin in the treatment of major depressive disorder.
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Wednesday, November 27, 2019
Sunovion announced the resubmission of the NDA to the FDA for apomorphine sublingual film to treat motor fluctuations.
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Wednesday, November 27, 2019
Verrica announced its NDA for VP-102, a proprietary topical therapy for the treatment of molluscum contagiosum, has been accepted for filing by the ...
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Monday, December 02, 2019
Mylan and Biocon announced the U.S. launch of Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab).
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Tuesday, December 03, 2019
Orchard Therapeutics announced the European Medicines Agency has validated the company’s MAA for OTL-200.
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Wednesday, December 04, 2019
Rafael Pharmaceuticals announced the expansion of its Phase 2 clinical trial of CPI-613® (devimistat) for patients with relapsed or refractory Burkitt...
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Wednesday, December 04, 2019
SK Life Science announced that the FDA has accepted its IND application for SKL24741 for epilepsy.
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