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Ocular Therapeutix resubmits Dextenza to FDA seeking approval for post-surgical ocular pain
firstwordpharma
January 24, 2017
Ocular Therapeutix on Monday said it resubmitted Dextenza (dexamethasone) to the FDA seeking approval for the treatment of ocular pain occurring after ophthalmic surgery.
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EU approval for c’s type 2 diabetes treatment
europeanpharmaceuticalreview
January 20, 2017
The European Commission (EC) has granted marketing authorisation in Europe for Sanofi‘s Suliqua, a titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 di
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Zydus receives final approval from the USFDA for Methotrexate Tablets USP
firstwordpharma
January 19, 2017
Zydus Cadila has received the final approval from the USFDA to market Methotrexate Tablets USP, 2.5 mg, a chemotherapy drug used for leukemias, lymphomas, breast cancer, lung cancer, head and neck cancers and other cancers.
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Hikma Receives Approval For Sodium Oxybate Oral Solution
firstwordpharma
January 19, 2017
Hikma Pharmaceuticals PLC (Hikma) announces that its wholly owned US subsidiary, Roxane Laboratories, Inc. (Roxane), has received an approval from the US Food and Drug Administration for its Sodium Oxybate Oral Solution.
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BioNet received Thai FDA approval of the world’s only available Recombinant Monovalent Acellular Per
pharmaasia
January 11, 2017
BioNet's vaccine is the first recombinant monovalent Pertussis vaccine in the world to receive a MAA for booster indication in adolescents and adults.