Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...

Global and US biotech shares have recovered from their lows on signs that the chaos created by the Trump administration is ...

As artificial food dyes are becoming increasingly restricted at state and federal levels, some manufacturers are looking to ...

The FDA granted regenerative medicine advanced therapy designation to 4D-150 for the treatment of diabetic macular edema, ...

The FDA has issued a Complete Response Letter to Telix Pharmaceuticals regarding the NDA for TLX101-CDx for the imaging of gliomas.

The FDA granted fast track designation to urcosimod to treat neuropathic corneal pain, according to a press release from Okyo Pharma. Urcosimod, formerly called OK-101, is a “lipid conjugated chemerin ...

No, red dye 3 and red dye 40 are not the same. Red dye 40, made of a chemical compound called Allura red AC, is already ...

INX-315, a CDK2 inhibitor, gained FDA fast track status in CCNE1-positive platinum-resistant/refractory ovarian cancer.

Urcosimod has received FDA fast track designation for neuropathic corneal pain, enabling expedited regulatory processes and ...

Retail investor interest in Q32 Bio Inc picked up on Wednesday after the clinical-stage biotech said the U.S. Food and Drug ...

INX-315, a CDK2 inhibitor, received FDA fast track designation for patients with CCNE1-amplified platinum-resistant ovarian ...

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...