FibroBiologics moves experimental psoriasis therapy into FDA review

The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline

Savara resubmits FDA application for potential treatment in rare lung disease patients

The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer

SOFIE Biosciences doses first patient in Phase 3 trial of novel cancer imaging agent

The study will run across 18 sites and enroll roughly 200 patients over 24 months

Azenta to sell B Medical Systems for $63 million

The agreement to sell B Medical Systems marks a major step forward in simplifying the portfolio to prioritize our core capabilities with the highest strategic impact

Diamyd Medical accelerates Phase 3 Type 1 diabetes trial following FDA guidance

The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026

INOVIO’s DNA therapy for rare throat disease gets FDA review

INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway

Amneal and mAbxience score FDA green light for two Denosumab biosimilars

Hansa Biopharma submits FDA application for kidney transplant desensitization treatment

If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant

Abbott’s Volt PFA System gets FDA nod

AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life

Zydus Partners with Bioeq for US commercialisation rights for Nufymco

NUFYMCO BLA has been approved by the USFDA