The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...

FDA updates CAR T-cell therapy labels, easing monitoring requirements and expanding access for eligible patients in oncology.

Emapalumab is approved for both adults and pediatric (newborn and older) patients with MAS in Still disease with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.

The FDA has approved its requested updated versions of expanded warning labels for COVID-19 vaccines. As Healio previously ...

The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

Bristol Myers (BMY) receives FDA approval for label updates for Breyanzi and Abecma, that can ease access to the cancer cell ...

Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has given approval to label updates ...

FDA announced on Tuesday, June 24, 2025, that it has updated Compliance Program 7321.005, now titled General Food Labeling ...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to PathAI for its digital pathology image management ...

Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting a green light in ultra-rare kidney disease C3 glomerulopathy (C3G).

J&J acquired nipocalimab when it bought Momenta Pharmaceuticals in 2020 for $6.5 billion, saying at the time that around 240 million people worldwide suffer from some form of auto-antibody-driven ...

Science News: The Axiom-4 mission will be carrying 'Rebecsinib', the first cancer drug with active US FDA 'Investigational New Drug' (IND) status to be tested in mi.