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.
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 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
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 19, 2025 Insmed receives EC approval for Brinsupri to treat NCFB By PBR Staff Writer This is the first approved treatment for NCFB in the European Union (EU). Approval followed evaluation of data from the Phase III Aspen and Phase II Willow studies
Research & Development November 17, 2025 Sofinnova closes €650m healthcare fund for early-stage ventures By PBR Staff Writer The fund will focus on medical technology and biopharmaceutical companies that seek to meet pressing unmet clinical needs, leveraging Sofinnova’s multi-strategy platform and investment team. It will leverage
Production & Sales November 4, 2025 CNX Therapeutics expands CNS portfolio with Sativex acquisition By PBR Staff Writer Sativex is indicated for the enhancement of symptoms in adult patients experiencing moderate to severe spasticity due to multiple sclerosis (MS) who have not responded sufficiently to other
Research and Development (RD)Production & Sales October 28, 2025 Hovione finalises $100m investment for East Windsor site expansion in US By PBR Staff Writer Following expansion, the site will cover over 200,000ft² and feature new technologies in sustainably designed facilities. The initial phase of expansion comprises a 31,000ft² building that will accommodate
Research & Development October 15, 2025 iQure, University of Padova collaborate to investigate iQ-007 mechanism By PBR Staff Writer The collaboration aims to clarify the underlying mechanism of action of iQ-007. The results will assist in stratifying and identifying patients who may benefit from this astrocyte-targeted therapy,
Neurology October 9, 2025 Nilo Therapeutics raises $101m to develop neural circuit therapies By PBR Staff Writer The funding will facilitate the establishment of Nilo’s laboratories in New York City, the growth of the team, and the advancement of preclinical programmes. Furthermore, the company has appointed