The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of conditional marketing authorisation for ExCellThera's cryopreserved haematopoietic stem cell transplantation product, Zemcelpro.
Johnson & Johnson has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) to extend the use of the human interleukin (IL)-12 and IL-23 antagonist, Stelara (ustekinumab), for paediatric patients aged two and above with moderately to severely active Crohn's disease (CD).
Ferrer's FNP-223 has secured fast-track designation from the US Food and Drug Administration (FDA), intended to slow down the development of progressive supranuclear palsy (PSP), a neurodegenerative disease.
The US Food and Drug Administration (FDA) has granted fast track designation to SolasCure's investigational Aurase Wound Gel (AWG) for treating calciphylaxis ulcers.
Japan’s Mitsubishi Research Institute (MRI) and Astellas Pharma have signed a memorandum of understanding (MoU) to support Japanese drug-discovery startups.
GRIN Therapeutics has announced a collaboration with Angelini Pharma to develop and commercialise radiprodil outside of North America.
Henlius has secured orphan drug designation (ODD) for its anti-HER2 monoclonal antibody, HLX22, from the European Commission (EC) for gastric cancer treatment.
Orion Corporation and Shilpa Medicare’s fully-owned subsidiary Shilpa Biocare, have entered into an agreement to commercialise recombinant human albumin in Europe.
Roche’s Genentech has gained the US Food and Drug Administration (FDA) approval for Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy (DR).
AI-enabled biotech company Juvenescence has announced the first close of its Series B-1 funding round, securing $76m to progress its therapeutic portfolio into clinical development.
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