REGENXBIO receives FDA response for RGX-121 application
The FDA accepted the gene therapy’s application under the accelerated approval pathway in May 2025. The CRL indicated that the FDA agreed in principle with the study protocol
The FDA accepted the gene therapy’s application under the accelerated approval pathway in May 2025. The CRL indicated that the FDA agreed in principle with the study protocol
The Takeda-Iambic AI drug discovery collaboration will initially focus on projects in oncology and gastrointestinal therapeutic area, as well as that of inflammation. Through this arrangement, Takeda will
The partnership represents the seventh agreement between the two companies and aims to expedite the delivery of new therapies to patients worldwide. Under the agreement, Innovent will utilise
Set to open in 2029, the facility will cover approximately 466,000ft² and accommodate 1,000 employees. The centre will connect with other Novartis global research locations in Basel, Switzerland,
The company’s fourth quarter revenues increased 1% to $12.5bn, and its growth portfolio surged 16% to $7.4bn. BMS reported non-GAAP earnings per share (EPS) of $6.15 for the
This contract enables Apotex to seek marketing authorisation and distribute the product in the country through its branded medicine division, Searchlight Pharma, once regulatory approval is secured. Grünenthal
Under this agreement, Everest Medicines will make potential regulatory and commercial milestone payments of up to 1.04bn yuan ($149m) and an upfront payment of 200m yuan. Furthermore, Micot
The agreement aims to advance PrimeGen US’s stem cell research and development and will provide access to public markets capital for progressing clinical studies, regulatory activities, and potential
The designation covers adults with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutant, hormone receptor positive, HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression after treatment with
Samsung Biologics is set to become part of CEPI’s Vaccine Manufacturing Facility Network (VMFN), aiming to speed up the availability of protein-based vaccines and improve access during outbreaks