Caplin Steriles gets USFDA approval for potassium phosphates injection

APL Healthcare’s Unit-IV classified as VAI by the USFDA

This inspection is now closed

Amydis bags $2.5 million NIH grant to develop first eye test for key ALS biomarker

Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA

Marks significant milestone for breakthrough biologic to treat rare blood cancers

FDA nod to first treatment for rare genetic brain disorder

The approval comes after a systematic review of published literature

Kainova reports positive Phase I results for receptor antagonist targeting advanced tumors

Phase I EPRAD study of DT-9081 demonstrated a favorable safety profile

Roche reports Phase III persevERA breast cancer trial results

Giredestrant shows promise despite missing primary goal

Codis expands UK manufacturing with groundbreaking spray dryer

The new equipment will be installed at Codis’ 400,000-square-foot Haverhill facility and is expected to be operational by 2027

UK pushes space-made medicines from orbit to patients with new support package

The initiative provides clearer regulatory guidance and a defined path from research in space to patient access on Earth

Lifecore Biomedical teams up with Indomo to advance at-home acne therapy

Indomo’s ClearPen system combines a proprietary self-injection device and microneedle with a modernized triamcinolone acetonide formulation