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APL Healthcare’s Unit-IV classified as VAI by the USFDA
News | March 14, 2026

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

This inspection is now closed


Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA
Drug Approval | March 13, 2026

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
Drug Approval | March 12, 2026

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
Clinical Trials | March 12, 2026

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
Clinical Trials | March 11, 2026

Roche reports Phase III persevERA breast cancer trial results

Giredestrant shows promise despite missing primary goal


Codis expands UK manufacturing with groundbreaking spray dryer
Medical Device | March 10, 2026

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
R&D | March 10, 2026

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
Biopharma | March 10, 2026

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