Browsing Tag
US FDA
379 posts
Novartis bags Kesimpta FDA approval for relapsing forms of MS
Kesimpta FDA approval for RMS: Novartis has bagged approval from the US Food and Drug Administration (FDA) for…
Kazia Therapeutics gets US RPDD for paxalisib in childhood brain cancer
Kazia Therapeutics, an Australian biotech company, has secured the rare pediatric disease designation (RPDD) for paxalisib (formerly GDC-0084)…
Farxiga : AstraZeneca gets FDA fast track status for heart failure after MI
AstraZeneca has secured fast track designation for Farxiga (dapagliflozin) in the US for its use in reducing the…
Ascentage Pharma gets FDA ODD for APG-2575 in Waldenström macroglobulinemia
Ascentage Pharma has been granted orphan drug designation (ODD) for its Bcl-2 inhibitor APG-2575 from the US Food…
BNT162b1 and BNT162b2 Covid-19 vaccine candidates get FDA fast track status
Pfizer and BioNTech said that BNT162b1 and BNT162b2, two vaccine candidates developed to give protection against the SARS-CoV-2…
Deciphera gets Qinlock FDA approval for fourth-line advanced GIST
Qinlock FDA approval : Deciphera Pharmaceuticals has been granted approval from the US Food and Drug Administration (FDA)…
Roche cobas HPV test for cervical screening gets FDA nod for use on cobas 6800/8800 Systems
Swiss healthcare company Roche has bagged approval from the US Food and Drug Administration to use its cobas…
Thermo Fisher coronavirus diagnostic test gets FDA’s emergency use order
Thermo Fisher Scientific has been granted an emergency use authorization (EUA) for its coronavirus diagnostic test from the…
Sorrento Therapeutics turns down $993m takeover bid from private equity firm
Sorrento Therapeutics, a California-based biopharma company, has turned down a takeover bid worth about $993 million from an…
TenNor Therapeutics gets FDA orphan drug status for TNP-2092 in prosthetic joint infections
TenNor Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its multitargeting…