In a landmark decision poised to revolutionize drug development, the U.S. Food and Drug Administration (FDA) has announced a ...

The U.S. Food and Drug Administration has approved a self-injection version of Vyvgart Hytrulo (efgartigimod alfa and ...

The U.S. Food and Drug Administration (FDA) has announced an ambitious effort to modernize drug testing by reducing reliance ...

After proper training on subcutaneous injection technique, the prefilled syringe may be administered by the patient or caregiver.

The FDA has announced plans to replace animal testing for many drugs in favor of AI and human-based lab models. The new ...

Emulate, Inc., a leading provider of next-generation in vitro models, today welcomed the U.S. Food and Drug Administration’s (FDA) newly announced plan to reduce reliance on animal testing in ...

RFK Jr. should accept the ruling and instruct the agency to immediately halt all efforts to regulate laboratory-developed and ...

San Antonio's Texas Biomed CEO responds to potentially major changes in the FDA's approach to drug development research.

Turbett Surgical is excited to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance ...

Nyxoah is actively addressing one remaining item before FDA approval may be granted which is the validation of one process ...

The U.S. FDA’s January 2025 draft guidance for test validation in public health emergencies drew only six responses, but pointed responses they were, indeed. As an example, the Association for ...

Current regulatory authorities (WHO, EMA and US FDA) limited the accepted amounts of residual DNA in biological products ... In this webinar, we share the development and validation of a new, highly ...