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After inspecting a facility owned by its US-based unit, Aurobindo Pharma reported that the US health regulator had made one observation. The Pre-Approval Inspection and GMP inspections by the USFDA were carried out at the Raleigh based plant from August 22–26.
Alembic Pharmaceuticals Limited announced that its Abbreviated New Drug Application (ANDA) for Chlorthalidone Tablets USP, 25 mg and 50 mg had been given final approval by the US Food & Drug Administration.
Lupin announced that it has received a provisional approval from the US health regulator to market Dasatinib tablets-used to treat specific types of cancer-in the US in dose levels of 20, 50, 70, 80, 100, and 140 mg.
The European Commission (EC) has authorised Scemblix (asciminib) for the treatment of adult patients with chronic myeloid leukaemia that is in the chronic phase and has the Philadelphia chromosome.
The government has identified 139 formulations, including medications like Remdesivir, influenza medications, Tocilizumab, some patented drugs, among others, and plans to implement trade margin rationalization in stages.
Data from a Kerendia (finerenone) Phase III trial were released by Bayer, demonstrating the drug’s potential to lower the risk of cardiovascular and all-cause mortality in type 2 diabetes.
Farxiga (dapagliflozin), a diabetes drug, is the
first heart failure (HF) medication to show
mortality benefits for all forms of HF, according
to a pre-specified pooled analysis from
AstraZeneca’s Phase III trial in patients with HF.
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