It is currently the only vaccine authorized by the Drug Controller General of India (DCGI) for active immunization against HEV in adults aged 18 to 65
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline
Applications include detailed scientific rationale and supporting clinical evidence
The applications aim to launch Phase Ib/II trials for relapsed/refractory multiple myeloma and primary plasma cell leukemia, respectively
Lupin has bolstered its diabetes and obesity portfolios by securing an agreement for Bofanglutide, a GLP-1 receptor agonist developed by Gan & Lee Pharmaceuticals
Patients with BRCA mutations often face aggressive disease and poor prognosis
Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia
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