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Gilead Sciences bags Remdesivir FDA approval for Covid-19 treatment

Gilead Sciences bags Remdesivir FDA approval for Covid-19 treatment

Remdesivir FDA approval : Gilead Sciences, a California-based biopharma company, has bagged approval from the US Food and Drug Administration (FDA) for its antiviral drug Veklury (remdesivir) for Covid-19 treatment in patients requiring hospitalization. This makes remdesivir the first approved treatment for coronavirus in the US. Remdesivir FDA approved indication : Veklury has been approved […]

AstraZeneca gets FDA breakthrough status for Farxiga in CKD

AstraZeneca has been granted breakthrough therapy designation (BTD) for Farxiga (dapagliflozin) from the US Food and Drug Administration (FDA) for the treatment of patients with chronic kidney disease (CKD), irrespective of type 2 diabetes (T2D). According to the US Centers for Disease Control and Prevention (CDC), chronic kidney disease is a serious, progressive condition defined […]

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FDA approves BMS’ Opdivo, Yervoy combo for malignant pleural mesothelioma

Bristol Myers Squibb (BMS) has secured approval for Opdivo (nivolumab) and Yervoy (ipilimumab) combination from the US Food and Drug Administration (FDA) for the first-line treatment of unresectable malignant pleural mesothelioma (MPM) in adults. The approval is for Opdivo 360 mg every three weeks with 1 mg/kg every six weeks (injections for intravenous use) of […]

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Rocket Pharmaceuticals gets FDA fast track status for RP-L401 in infantile malignant osteopetrosis

Rocket Pharmaceuticals has secured fast track designation for RP-L401 gene therapy candidate from the US Food and Drug Administration (FDA) for the treatment of infantile malignant osteopetrosis (IMO). RP-L401 is a lentiviral vector (LVV)-based gene therapy which is being studied in a non-randomized, open-label phase 1 clinical trial for the treatment of the rare childhood […]

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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 been granted an expanded approval from the US Food and Drug Administration (FDA) for the DKd regimen comprising the former’s DARZALEX (daratumumab) and the latter’s Kyprolis (carfilzomib) plus dexamethasone for the treatment of multiple myeloma. The approval […]

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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 Administration (FDA) for paxalisib (formerly GDC-0084) for the treatment of glioblastoma. The specific indication for which the designation has been granted is for newly diagnosed glioblastoma patients with unmethylated O6-Methylguaninemethyltransferase (MGMT) promotor status who had initial radiation […]

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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 its blood cancer drug Kesimpta (ofatumumab, formerly OMB157) for the treatment of relapsing forms of multiple sclerosis (RMS). The approval is for the use of the anti-CD20 monoclonal antibody (mAb) as a subcutaneous injection in clinically isolated syndrome, […]

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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 and Drug Administration (FDA) for the treatment of Chagas disease in pediatric patients, from newly born to less than 18 years of age, weighing at least 2.5kg. Chagas disease is an infectious tropical disease caused by Trypanosoma […]

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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 risk of hospitalization for heart failure (hHF) or cardiovascular (CV) death in adults after an acute myocardial infarction (MI) or heart attack. The fast track designation for the oral once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor is based on […]

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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 Drug Administration (FDA) to move ahead with a phase 2 clinical trial for investigating the efficacy of autologous adipose tissue-derived mesenchymal stem cells (AdMSCs) in the prevention of Covid-19. In this connection, the Texas-based biotech company had […]

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