iRegene’s Parkinson’s therapy gains FDA designation

The RMAT designation accelerates the development of regenerative medicine therapies for serious or life-threatening diseases

Brenig Therapeutics launches first-in-human trial of novel neurodegenerative therapy

The Phase 1 single and multiple ascending dose study is set to begin dosing in early Q1 2026

Miach Orthopaedics’ BEAR implant gains FDA label claim for reduced arthritis risk

The BEAR Implant is the first sports medicine device to carry a label claim related to lowering PTOA risk

Lantern Pharma launches AI Center of Excellence in Bengaluru to scale precision drug discovery globally

Dr. Reddy's launches novel recombinant Hepatitis E vaccine ‘Hevaxin’ in India

It is currently the only vaccine authorized by the Drug Controller General of India (DCGI) for active immunization against HEV in adults aged 18 to 65

RedHill Biopharma advances RHB-102 as once-daily oral therapy to combat GLP-1 side effects

The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation

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