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

GenSight Biologics gets early access nod for candidate gene therapy in Israel

Applications include detailed scientific rationale and supporting clinical evidence

CARsgen submits INDs for next-gen CAR-T therapy targeting hard-to-treat blood cancers

The applications aim to launch Phase Ib/II trials for relapsed/refractory multiple myeloma and primary plasma cell leukemia, respectively

Lupin and Gan & Lee enter exclusive licensing deal for novel GLP-1 receptor agonist

Lupin has bolstered its diabetes and obesity portfolios by securing an agreement for Bofanglutide, a GLP-1 receptor agonist developed by Gan & Lee Pharmaceuticals

Zydus signs exclusive agreement with Myriad Genetics of US to launch cancer-risk assessment diagnostic tests in India

FDA nod to Johnson & Johnson’s AKEEGA for aggressive prostate cancer

Patients with BRCA mutations often face aggressive disease and poor prognosis

Sanofi secures two breakthrough nods in China for rare blood disorders

Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia

GSK’s experimental lung cancer drug gains FDA orphan drug status

GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization

Formation Bio snaps up global rights to next-gen CNS TYK2 inhibitor from Lynk Pharma

LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure

Debiopharm launches pivotal phase III trial for novel quarterly acromegaly treatment

Acromegaly, a rare chronic endocrine disorder caused by excess growth hormone, is seeing promising advances in treatment development