Related coverage linked through entity extraction aliases.
Jul 12, 2026
Savara resubmits BLA with near-term FDA decision expected; Sarepta reports $331M in Q1 net product revenue but Elevidys sales continue to decline; AstraZeneca stock falls ahead of July 2026 earnings release.
Jun 11, 2026
Japan's health ministry panel is reviewing two regenerative cell therapies for Parkinson's disease and heart failure, testing the country's push to build a domestic cell-based treatment industry. Japan's cell culture market is projected to reach USD 2.34 billion by 2031, driven by government support and favorable regulatory pathways. Australian firm Cartherics secured a Japanese patent for its iPSC-based immune cell therapies.
Apr 17, 2026
The FDA extended by three months the review period for Savara's MOLBREEVI biologics license application in autoimmune pulmonary alveolar proteinosis, moving the PDUFA date to Nov. 22, 2026. Savara had previously said the FDA filed the application after a resubmission tied to manufacturing data and a transfer to Fujifilm.
Mar 23, 2026
Fujifilm Biotechnologies has opened the UK's largest single-use biopharmaceutical CDMO facility in Teesside with a £400 million investment. The 110,000 sq ft facility features 19,000 liters of bioreactor capacity and will be operational in H1 2026. The expansion includes a new Bioprocess Innovation Centre that doubles the site's lab footprint.
Feb 16, 2026
Savara Inc. announced the FDA has accepted its resubmitted Biologics License Application for MOLBREEVI, a treatment for autoimmune pulmonary alveolar proteinosis, with Priority Review granted and a target decision date of August 22, 2026.
