FDA approved Cablivi (caplacizumab-yhdp) for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura
Posted on12 Feb 2019
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The USFDA approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment... Read More
Insight on EU’s safety features of unique identifier & anti-tampering device on outer packaging require for medicines
As of 9 February 2019, most prescription medicines and some over-the-counter medicines for human use supplied in the European Union are required... Read More
Glenmark Specialty S.A’s exclusive licensing agreement with Grandpharma (China) Co. Ltd for commercializing Ryaltris in China
Posted on07 Feb 2019
TagsGlemark outlicensing, global pharma licensing deal, licensing deal in pharma, outlicensing in pharma
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Glenmark Pharmaceuticals Ltd, a research-led global integrated pharmaceutical company, announced that its Swiss subsidiary, Glenmark Specialty S.A, has entered into an exclusive... Read More
USFDA approved first generic of Advair Diskus
The U.S. Food and Drug Administration today approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the... Read More
USFDA accepted the Roche’s sBLA for Tecentriq (atezolizumab) in combination with Abraxane
Posted on30 Jan 2019
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US Food and Drug Administration (FDA) has accepted the Roche’s supplemental Biologics License Application (sBLA) for Tecentriq® (atezolizumab) in combination with Abraxane®... Read More
USFDA approved Imbruvica in combo with obinutuzumab for adult patients with previously untreated CLL/SLL
AbbVie, a research-based global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) approved the use of Imbruvica (ibrutinib) in... Read More
US FDA approval of 0.5 ml dose of Sanofi’s Fluzone Quadrivalent in children as young as 6 months of age
The US Food and Drug Administration (FDA) has approved the use of the 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) to... Read More
Key Insights on 2018 USFDA new drug approval
USFDA new drug appproval year by year Year Number of New Molecule Approved by USFDA 2018 59 >> Highest number of new... Read More
Sandoz introduces Symjepi 0.3 mg injection in US market to treat allergic reactions
Sandoz Inc, a Novartis division, announced the US market introduction of Symjepi (epinephrine) 0.3 mg injection for the emergency treatment of allergic... Read More