Drug Approval | November 15, 2021
Zydus Cadila receives tentative approval for IBS tablets
The group now has 324 approvals and has so far filed over 400 ANDAs
The group now has 324 approvals and has so far filed over 400 ANDAs
The European Commission (EC) granted marketing authorisation for Celltrion’s regdanvimab following a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last week
Data demonstrates Ronapreve reduced risk of hospitalisation in certain patients and reduced risk of symptomatic Covid-19 infections in people exposed to the virus
A final decision regarding the approval of Ronapreve is expected from the European Commission shortly
The ground-breaking project, led by Genomics England and NHS England, was established in 2013 to sequence 100,000 whole genomes from NHS patients and their families
Glycopyrrolate injection can also be used in adults as an adjunctive therapy for the treatment of gastrointestinal ulcer when a rapid effect is desired or when oral medication is not tolerated
The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11
Bioanalytical approach to accelerate development efforts in the identification of compounds that can treat chlorine or sulfur mustard injuries
Positive results reinforce the improved efficacy seen with Opdivo-based treatments in four Phase 3 clinical trials in earlier-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma
Biocon Biologics and Viatris co-developed the products
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