Also known as: MHRA, U.K. Medicines and Healthcare products Regulatory Agency, UK Medicines and Healthcare products Regulatory Agency, U.K. Medicines and Healthcare Products Regulatory Agency, UK Medicines and Healthcare Products Regulatory Agency
Cell and Gene Therapy Catapult has established a Technology Advisory Board to support technology deployment across advanced therapies. The board will focus on data, manufacturing, testing and patient pathways.
Tumour-infiltrating lymphocyte therapy has shown durable responses in refractory melanoma, including a 31.4% objective response rate in phase II data. The 2024 FDA approval of Lifileucel marked a milestone as regulators in other markets continue reviews.
EMA has initiated a rolling review of OS Therapies' OST-HER2 for preventing recurrence in fully resected pulmonary metastatic osteosarcoma. A potential conditional marketing authorization decision is expected in Q4 2026, with a confirmatory Phase 3 trial planned for Q3 2026 in Australia.
LENZ Therapeutics submitted a UK marketing authorization application for VIZZ for presbyopia on April 20, 2026. The filing follows FDA approval in July 2025 and EMA validation in March 2026.
The UK is offering £20 million through Innovate UK to develop medicines, devices and digital tools for drug and alcohol addiction. Awards range up to £10 million for late-stage projects and up to £1.5 million for earlier-stage innovations, with applications closing on 6 May 2026.
The FDA has accepted Savara’s BLA for MOLBREEVI in autoimmune PAP and granted Priority Review with an action date of August 22, 2026. The application includes data showing improved pulmonary gas transfer, quality of life, and clinical symptoms.
Egetis Therapeutics completed its rolling New Drug Application for Emcitate® (tiratricol) for MCT8 deficiency in the USA on January 29, 2026. The drug received European Commission approval in February 2025 and launched in Germany in May 2025. The company also provided updates on Japanese regulatory progress and the status of its Aladote® candidate for paracetamol overdose.
Aquestive Therapeutics received a Complete Response Letter from the FDA for Anaphylm (dibutepinephrine) sublingual film, citing deficiencies in human factors validation and packaging. The company plans to resubmit as early as Q3 2026.
Savara has submitted a Biologics License Application for MOLBREEVI to the FDA with Priority Review status, targeting an August 22, 2026 decision date for treating autoimmune pulmonary alveolar proteinosis.
FDA elevated OS Therapies' Type D meeting to Type B pre-BLA meeting for OST-HER2 in osteosarcoma, signaling transition to Accelerated Approval discussions. Clinical data submission targeted for end of Q1 2026.
