Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla
The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia
The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia
The therapy -- Ryoncil (remestemcel-L-rknd) -- will be tested in adults with severe steroid-refractory acute graft-versus-host disease
Winlevi is authorized in EU for the treatment of acne vulgaris
The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
The multibillion-dollar Maryland expansion is part of AstraZeneca’s sweeping $50 billion global investment plan
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
The study successfully met its primary endpoint, demonstrating similar rates of viral suppression for DOR/ISL compared to Biktarvy at 48 weeks
The collaboration to develop breakthrough myeloid cell engagers (MCEs) signals a bold push into a promising new frontier in cancer therapy
The formulation is backed by over 80 clinical trials and 200 scientific publications
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