RedHill Biopharma’s RHB-204 granted FDA fast track designation for NTM disease
The FDA’s Fast Track designation is designed to help progress development and speed up the review of novel therapies for serious conditions for which there is an unmet
Ionis Pharmaceuticals has entered a licence agreement granting global pharmaceutical company Recordati exclusive rights to develop and commercialise zilganersen to treat Alexander disease (AxD) in countries outside the US.
Fujifilm stated that it is establishing the new manufacturing site to boost the growth of its biopharmaceutical contract development and manufacturing business (CDMO). The company’s subsidiary Fujifilm Diosynth
CURE is seeking approval of this product via the 505(b)(2) regulatory pathway to expedite the U.S. approval process. CUREfilm Blue utilizes the Company’s patented and proprietary fast-dissolving drug