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

Enveda launches Phase 1 trial for first-in-class Oral IBD therapy

The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ENV-6946 in healthy volunteers

Zydus Partners with Bioeq for US commercialisation rights for Nufymco

NUFYMCO BLA has been approved by the USFDA

Alvotech, Teva secure US settlement with Regeneron for Eylea biosimilar launch

Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026

GSK’s Exdensur gains FDA nod for severe asthma with just two doses a year

The approval for Exdensur (depemokimab-ulaa) comes on the back of SWIFT-1 and SWIFT-2 Phase III trials

Lupin receives positive CHMP opinion for biosimilar Ranibizumab

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A