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.
Wednesday, January 29, 2020
Pharmacosmos announced the FDA has approved Monoferric injection 100 mg/mL.
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Thursday, January 16, 2020
Lannett announced the FDA has approved the NDA, submitted under the 505(b)(2) regulatory pathway, for Cocaine Hydrochloride Nasal Solution 4%.
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Nabriva announced the FDA has acknowledged receipt of its NDA resubmission for marketing approval of CONTEPO for injection for the treatment of cUTIs.
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Tuesday, January 07, 2020
Novo Nordisk announced the FDA has approved Fiasp 100 u/mL for use as a new mealtime insulin option for children with diabetes.
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Savara announced the FDA has granted Breakthrough Therapy designation for Molgradex, an inhaled formulation of recombinant human GM-CSF, for the ...
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Thursday, January 02, 2020
DUR-928 did not demonstrate a benefit over vehicle (placebo) based on IGA, which was the scoring system for the primary analysis, or in any of the ...
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Monday, December 23, 2019
VERO Biotech has received FDA approval of GENOSYL (nitric oxide) gas, for inhalation.
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Friday, December 20, 2019
Nabriva Therapeutics has resubmitted its NDA to the FDA for CONTEPO for injection for the treatment of complicated urinary tract infections.
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Monday, December 16, 2019
Avenue Therapeutics has submitted a NDA to the FDA for IV tramadol for moderate to moderately severe pain in adults in a medically supervised health ...
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Friday, December 06, 2019
Applied Pharma Research announced the FDA has granted ODD for its investigational drug code-named APR-TD011 for treatment of Epidermolysis Bullosa.
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Wednesday, December 04, 2019
Healthy Humming has announced positive topline data from a prospective outcomes study, which assessed the safety and efficacy of the SinuSonic.
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Tuesday, December 03, 2019
Seelos announced the dosing of the first subjects in a Phase I Pharmacokinetic and Pharmacodynamic profile study, SLS-002-102.
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Tuesday, December 03, 2019
OWP has received IND approval from the FDA, and has submitted for U.S. patent protection, for the first liquid formulation of lamotrigine.
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Monday, December 02, 2019
Cumberland Pharmaceuticals has received approval from the FDA for RediTrex™, its new line of methotrexate products.
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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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