Browsing Tag
FDA
341 posts
Janssen, Amgen secure FDA approval for DKd regiment in multiple myeloma
DKd regiment FDA approval for multiple myeloma : Janssen Pharmaceutical Companies of Johnson & Johnson and Amgen have…
Kazia Therapeutics gets fast track status for paxalisib in glioblastoma
Kazia Therapeutics, an Australian oncology company, has secured fast track designation (FTD) from the US Food and Drug…
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…
Bayer gets Lampit FDA approval for Chagas disease in pediatric patients
Lampit FDA approval : Bayer has bagged approval for its antiprotozoal medication Lampit (nifurtimox) from the US Food…
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…
Celltex Therapeutics gets FDA nod for Covid-19 stem cell clinical trial
Covid-19 stem cell clinical trial : Celltex Therapeutics has been given the clearance by the US Food and…
Reneo Pharmaceuticals gets FDA ODD for REN001 in primary mitochondrial myopathies
Reneo Pharmaceuticals has been granted the orphan drug designation (ODD) for its lead drug candidate REN001 from the…
Leap Therapeutics gets FDA orphan status for DKN-01 for gastric and gastroesophageal junction cancer
US immuno-oncology company Leap Therapeutics has been granted orphan drug designation for DKN-01 from the US Food and…
Cipla gets FDA’s final approval for generic version of Migranal with CGT designation
Cipla has secured final approval for its abbreviated new drug application (ANDA) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL…
Quidel’s Lyra Direct SARS-CoV-2 Assay gets FDA EUA status for molecular detection of COVID-19
Quidel has been given emergency use authorization from the US Food and Drug Administration (FDA) for its Lyra…