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.
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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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 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 23, 2019
VERO Biotech has received FDA approval of GENOSYL (nitric oxide) gas, for inhalation.
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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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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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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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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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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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Wednesday, January 29, 2020
Pharmacosmos announced the FDA has approved Monoferric injection 100 mg/mL.
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Tuesday, February 11, 2020
Oculis reports positive data from a phase 2 study of OCS-01, a novel eye drop formulation of dexamethasone, in development for the treatment of ...
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Friday, February 14, 2020
Avenue Therapeutics announced the FDA has accepted for review Avenue’s NDA for IV tramadol for the management of moderate to moderately severe pain in...
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Wednesday, February 19, 2020
Diasome announced positive results from its Phase 2 OPTI-1 study of injectable hepatocyte directed vesicle added to mealtime insulin in people with ...
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Friday, February 21, 2020
Companion Medical announced clearance by the FDA for the use of Novo Nordisk's Fiasp® rapid-acting insulin.
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Monday, February 24, 2020
United Therapeutics and DEKA announced receipt of an additional 510(k) clearance by the FDA related to the Unity Subcutaneous Delivery System for ...
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