Browsing Tag
FDA
293 posts
EC approves ADCETRIS for treating CD30+ Stage IV Hodgkin lymphoma
The European Commission (EC) has officially expanded the approval of Takeda Pharmaceutical’s ADCETRIS (brentuximab vedotin) to include the…
Samsung Bioepis partners with C-Bridge Capital to expand biosimilar portfolio in China
Samsung Bioepis, a South Korean leader in biopharmaceuticals, has struck a deal with private equity firm C-Bridge Capital…
Ablynx secures FDA approval for Cablivi to treat aTTP
In a significant milestone for Belgian biopharma company Ablynx, the U.S. Food and Drug Administration (FDA) has granted…
Pulmazole phase 2 clinical study gets FDA approval for Pulmazole in allergic bronchopulmonary aspergillosis
Pulmatrix, the Massachusetts-based biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to initiate…
Prana Biotechnology secures FDA orphan drug status for PBT434 to treat multiple system atrophy
In a significant milestone, Prana Biotechnology, an Australian biotech company, has obtained Orphan Drug designation from the FDA…
X-Rx announces FDA acceptance of IND for X-165, a potential treatment for Idiopathic Pulmonary Fibrosis
US-based biotech company X-Rx has received a major boost in its quest to develop new treatments for Idiopathic…
FDA accepts review of Kala Pharmaceuticals’ new dry eye treatment KPI-121 0.25%
The United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for KPI-121 0.25%,…
Armas Pharmaceuticals launches first injectable in US with Vidaza generic
Armas Pharmaceuticals has entered the US injectable drug market with its launch of Azacitidine for Injection 100 MG,…
FDA approves once-weekly dosing for Amgen’s Kyprolis in multiple myeloma treatment
The United States Food and Drug Administration (FDA) has granted approval for a new once-weekly dosing regimen of…
Almirall completes $550m acquisition of five dermatology brands from Allergan
In a significant move within the pharmaceutical industry, Spanish pharmaceutical company Almirall has finalised its $550 million acquisition…