ProBioGen, Zag Bio seal manufacturing deal to fast-track type 1 diabetes therapy into clinic

The work will leverage ProBioGen’s CHO.RiGHT expression platform, powered by its proprietary DirectedLuck transposase technology, alongside PsiBot smart automation

Subcutaneous Saphnelo cuts lupus disease activity in phase III trial

SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage

Incyte eyes first-line nod for Tafasitamab in aggressive lymphoma

Diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL) in adults, represents 40% of all cases worldwide

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

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

InnoCare Pharma gets green light for Phase II trial of oral lupus drug

CLE, a common form of lupus erythematosus, primarily causes diverse skin lesions

Amneal and mAbxience score FDA green light for two Denosumab biosimilars

Kashiv BioSciences secures Rs. 684 crore funding to build one of India’s largest biopharma facilities

The new single-use commercial facility will be among India’s largest, featuring advanced technologies to produce high-quality biologics and specialty pharmaceuticals

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