Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of USFDA’s Priority Review action date
The USFDA approval in AS marks the fifth indication for Rinvoq in chronic immune-mediated diseases
Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo
Biocon Biologics’ Insugen formulations will be available to patients at all Ministry of Health hospitals, district health offices and health clinics
The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the USFDA for an EV therapeutic
If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients
Yescarta is First CAR T-cell therapy to receive NCCN treatment guideline category 1 recommendation --
Ozempic is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults
The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial
The company plans to launch the product immediately
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