Approvals December 1, 2025 US FDA approves Lupin’s Armlupeg injection By PBR Staff Writer The company will manufacture the product at its biotechnology facility in Pune, India, which has undergone a previous FDA inspection. Armlupeg is indicated to reduce the risk of
ApprovalsResearch & Development November 28, 2025 IASO Bio gains Hong Kong approval for Fucaso application By Salong Debbarma The therapy is intended for patients who have undergone at least three previous therapies, including an immunomodulatory agent and a proteasome inhibitor. The approval is the first authorisation
Approvals November 28, 2025 MHRA approves Roche Products’ inavolisib for breast cancer By Salong Debbarma The approval enables the use of inavolisib in patients whose cancer has recurred during or shortly after hormone therapy and has metastasised to other areas of the body.
Research & Development November 27, 2025 BeOne’s sonrotoclax gains priority FDA review for mantle cell lymphoma By PBR Staff Writer The decision is intended for those who have previously been treated with a Bruton’s tyrosine kinase (BTK) inhibitor. This application is based on data from a global, open-label,
Production & Sales November 27, 2025 Corstasis Therapeutics partners CVL for Enbumyst integration By Salong Debbarma The approach is consistent with outpatient settings as per US Food and Drug Administration (FDA)-approved use. The initiative enhances access to non-oral diuretic therapy throughout CVL’s cardiovascular practice
Research & Development November 26, 2025 UNICEF and Gavi to widen affordable malaria vaccine access By PBR Staff Writer The deal sets the vaccine price at $2.99 per dose and is expected to take effect within a year, supporting Gavi’s goal to fully vaccinate 50 million more
Research & Development November 26, 2025 FDA grants accelerated approval for Otsuka’s IgAN therapy By PBR Staff Writer Voyxact is administered as a self-injected subcutaneous dose every four weeks. Its approval was based on the interim results of the Phase III VISIONARY trial, which demonstrated a
Drug Manufacturing November 25, 2025 Made Scientific and Cellergy partner to advance CLG-001 By PBR Staff Writer Cellergy will utilise the good manufacturing practices (GMP) expertise of Made Scientific to enhance its mitochondrial isolation and purification process for the clinical-grade production of CLG-001. This work
Research & Development November 25, 2025 Novartis secures approval from FDA for Itvisma to treat SMA By PBR Staff Writer This therapy is intended for children aged two years and above, teens and adults with SMA who have a confirmed mutation in the survival motor neuron 1 (SMN1)
Research & Development November 24, 2025 AstraZeneca to expand biomanufacturing in Maryland, US By PBR Staff Writer The investment covers both expansion of the Frederick biologics manufacturing facility and a new plant construction in Gaithersburg, targeting operational readiness by 2029. The Frederick site, which produces