Home » Archives by category » Pharma Regulatory News
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 […]

Regeneron bags Inmazeb FDA approval for treatment of Ebola

Inmazeb FDA approval : Regeneron Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its antibody cocktail Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) for the treatment of Zaire ebolavirus (Ebola virus). Formerly known as REGN-EB3, Inmazeb is now the first drug regimen to get FDA approval for Ebola treatment, covering adult and […]

Continue reading …
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 […]

Continue reading …
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 […]

Continue reading …
Gilead, Galapagos bag Jyseleca EC approval for rheumatoid arthritis

Jyseleca EC approval : Gilead Sciences and Galapagos have secured marketing authorization for Jyseleca (filgotinib 200 mg and 100 mg tablets) from the European Commission (EC) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adults. The approval of the once-daily, oral, JAK1 inhibitor is rheumatoid arthritis patients who showed inadequate response […]

Continue reading …
Gan & Lee gets FDA orphan drug status for GLR2007 in malignant glioma

Gan & Lee Pharmaceuticals has been given orphan drug designation from the US Food and Drug Administration (FDA) for GLR2007 for the treatment of malignant glioma, an aggressive primary brain tumor. According to the Chinese biopharma company, GLR2007 is an inhibitor of cyclin-dependent kinase 4/6 (CDK 4/6), which is being developed for the treatment of […]

Continue reading …
FDA accepts Ascendis Pharma’s TransCon hGH BLA for pediatric GHD

Ascendis Pharma, a Danish biopharma company, said that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for TransCon hGH (lonapegsomatropin) for the treatment for pediatric growth hormone deficiency (GHD). TransCon hGH is an investigational long-acting prodrug of somatropin (human growth hormone or hGH). The FDA has set a Prescription […]

Continue reading …
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 […]

Continue reading …
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 […]

Continue reading …
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 […]

Continue reading …
Page 1 of 20123Next ›Last »