Gland Pharma beat muted expectations for Q2FY25. There was increased Ebitda (Earnings before interest, taxes, depreciation ...

Third quarter results highlight strong operational performance across key value drivers: YUPELRI® (revefenacin) net sales of $62.2 million, recognized by Viatris ...

for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. On November 12, 2024, the FDA granted the ...

The authorised ANDA is a therapeutic equivalent of the reference-listed drug (RLD), Corlanor tablets, in the same 5 mg and ...

The decision follows the U.S. Food and Drug Administration (FDA) clearance of an application submitted last year requesting ...

for its Abbreviated New Drug Application (ANDA) Ivabradine Tablets, 5 mg and 7.5 mg. The approved ANDA is therapeutically ...

The US health regulator granted final approval for Alembic Pharma's Abbreviated New Drug Application (ANDA) for Ivabradine ...

As it becomes clearer that Indian markets have to deal with domestic slowdown and increased uncertainty under Donald Trump’s ...

Alembic Pharmaceuticals (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ivabradine Tablets, 5 mg ...

The US FDA has cleared an investigational new drug (IND) application for HG202, by HuidaGene Therapeutics. This drug is the ...

This drug is the world’s first-ever CRISPR/Cas13 RNA-editing therapy for clinical use in treating neovascular age-related macular degeneration (nAMD). The US FDA has cleared an investigational new ...

they’ve withdrawn an approval application for a drug called datopotamab deruxtecan, or dato-dxd, in a common form of lung ...