Summary: Biocon Pharma has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for…
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Agrochemicals
The USFDA approves Qiagen’s QuantiFERON-TB Gold Plus Assay for use on DiaSorin’s automated Liaison XS Platform for TB Testing
by adminby adminKEYPOINTS: QIAGEN (QGEN) and DiaSorin said that the U.S. Food and Drug Administration has approved the LIAISON QuantiFERON-TB Gold Plus assay for…
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Nelarabine
Zydus Cadila receives USFDA Final Approval for Nelarabine Injection a Therapeutically Generic Version of Arranon injection.
by adminby adminKEYPOINTS: Zydus Cadila has received final approval from the US FDA to market Nelarabine injection 250MG/50ML in the United States. Zydus Pharmaceuticals…
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Agrochemicals
Alembic Pharma JV Aleor Derma Receives USFDA Approval for Mupirocin Cream a Therapeutically Generic Version of Bactroban Cream
by adminby adminSYNOPSIS: Alembic Pharmaceuticals Limited announced that its joint venture Aleor Dermaceuticals Limited has received final approval from the US Food & Drug…
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Active Pharmaceutical Ingredients (API)ATG-101Pharma Science & Research
Antengene Receives FDA Approval of IND for Phase 1 Trial of ATG-101 (PD-L1/4-1BB bispecific antibody) in Solid Tumors and Non-Hodgkin Lymphoma.
by adminby adminKEYPOINTS; Antengene Corporation Limited announced that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for…
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CompaniesNovartis
Novartis’s BLA has been accepted by US FDA & EMA for Kymriah (Tisagenlecleucel) to treat patients with relapsed or refractory follicular lymphoma.
by adminby adminNovartis says that the U.S. and European regulators have accepted its marketing applications for CAR-T cell therapy Kymriah (Tisagenlecleucel) as third-line therapy…
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Active Pharmaceutical Ingredients (API)BictegravirEmtricitabineTenofovir Alafenamide
USFDA Approves Expanded Indication of Gilead’s Biktarvy for Treatment of HIV-1 in Pediatric Populations
by adminby adminKeypoints FDA Approves Low-Dose Tablet for HIV Treatment in Virologically Suppressed Children Weighing at Least 14 kg. Biktarvy Provides an Effective Treatment…
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Active Agrochemical IngredientAtezolizumab
USFDA approves Roche’s Tecentriq (Atezolizumab) as Adjuvant Treatment for Non- small Cell Lung Cancer.
by adminby adminKeypoints USFDA approves Roche’s Tecentriq as adjuvant treatment for certain people with early NSCLC Tecentriq treatment reduced the risk of disease recurrence…
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RegulatoryU.S FDA
USFDA Panel endorses Johnson and Johnson COVID-19 Vaccine booster.
by adminby adminKeypoints J&J presented data to the 19-member committee indicating that its vaccine loses efficacy over time, and that a booster shot is…
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