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 for PBT434, its lead molecule aimed at ... Read More
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 Pulmonary Fibrosis (IPF) with the US Food ... Read More
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%, an investigational treatment developed by Kala Pharmaceuticals ... Read More
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, a generic version of Vidaza, targeting myelodysplastic ... Read More
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 Amgen's Kyprolis (carfilzomib) in combination with dexamethasone ... Read More
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 of five dermatology medications from Allergan's Medical ... Read More
Esketamine nasal spray misses key trial expectations, but Janssen remains optimistic
Janssen Pharmaceutical Companies of Johnson & Johnson encountered a significant setback with their esketamine nasal spray in a phase 3 trial aimed at treating patients ... Read More
Teva secures FDA approval for Ajovy injection in migraine prevention
Teva Pharmaceutical Industries has achieved a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) approving Ajovy (fremanezumab-vfrm) injection for migraine prevention in ... Read More
FDA declines approval for Sunovion’s ADHD drug dasotraline, citing need for more data
In a regulatory setback, the U.S. Food and Drug Administration (FDA) has decided not to approve Sunovion Pharmaceuticals’ dasotraline, a dual-acting dopamine and norepinephrine reuptake ... Read More