The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Unicycive Therapeutics’ New Drug ...

A Republican-backed amendment to the sweeping budget proposal championed by US president Donald Trump would sharply reduce ...

Swedish biotech Camurus (Nasdaq Stockholm: CAMX) has secured EU marketing authorization for its once-monthly acromegaly ...

Denmark-based Vesper Bio, a biotech developing an oral therapy for frontotemporal dementia, has announced the appointment of ...

Systemic sclerosis is an autoimmune connective tissue disease that causes debilitating fibrosis of the skin and internal ...

Despite major strides in antiretroviral therapy (ART), the human immunodeficiency virus (HIV) market still faces serious ...

Shares in US biotech INmune Bio slumped by around 60% following news that its Phase II Alzheimer’s study failed to hit its ...

As pressure builds around drug pricing and access, US trade group PhRMA is pushing back against criticism of pharmaceutical ...

Clinical-stage oncology company Revolution Medicines and fellow USA-based Summit Therapeutics have entered into a clinical ...

The US Food and Drug Administration (FDA) has approved Japanese pharma major Takeda’s Gammagard Liquid ERC [immune globulin ...

The US Food and Drug Administration (FDA) is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD)—including certain formulations ...

Chinese biopharma Hutchmed today announced that the New Drug Application (NDA) for the combination of Orpathys (savolitinib) ...