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news.Novartis secures approval from FDA for Itvisma to treat SMA
This therapy is intended for children aged two years and above, teens and adults with SMA who have a confirmed mutation in the survival motor neuron 1 (SMN1)
This therapy is intended for children aged two years and above, teens and adults with SMA who have a confirmed mutation in the survival motor neuron 1 (SMN1)
The investment covers both expansion of the Frederick biologics manufacturing facility and a new plant construction in Gaithersburg, targeting operational readiness by 2029. The Frederick site, which produces
The agreement includes an exclusivity period of six months for negotiating and finalising a definitive agreement, pending due diligence and board approvals. Vaximm is eligible for an upfront
This round will also bolster the company’s manufacturing offerings and support additional pipeline therapies. It was jointly led by OrbiMed, Frazier Life Sciences, ARCH Venture Partners and Revelation
The authorisations cover Gobivaz in both 100mg/ml and 50mg/0.5ml formulations, provided in pre-filled syringes with autoinjector formats and passive needle safety guards, to treat adults with axial spondyloarthritis,
This is in breach of the Texas Health Care Program Fraud Prevention Act. The ADHD drugs case centred on the medication Quillivant XR, provided to children on Medicaid.
The approval follows positive results from the Phase I/II GO29781 study, which demonstrated that Lunsumio SC has pharmacokinetic non-inferiority to intravenous (IV) administration. No unexpected safety issues were
The protection for this patent will last until 2037. Genprex has also obtained similar patent protection for the gene therapy used with PD-L1 antibodies in Korea, and is
This is the first approved treatment for NCFB in the European Union (EU). Approval followed evaluation of data from the Phase III Aspen and Phase II Willow studies
The acquisition brings Halda’s lead candidate, HLD-0915, a clinical-stage treatment for prostate cancer, into Johnson & Johnson’s oncology portfolio. This once-daily therapy presents an opportunity to enhance patient