19 October 2023
19 October 2023
The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.
The company also secured $50m in debt financing to support the commercial launch of Xphozah in November.
The FDA has pushed Livmarli’s PDUFA date to 13 March 2024, citing an information request deemed a major amendment.
The company has been awarded the designation for SAGE-718, which had previously received fast track status.
The data from the Phase II trial showed the efficacy of tipifarnib in patients with recurrent/metastatic head and neck squamous cell carcinoma.
The positive opinion expands the antiviral drug’s use to CMV-positive donors and CMV-negative kidney transplant patients at high risk of CMV infection.
The company has shown the safety and efficacy of its prototype vaccine as a primary series in individuals aged 12 and above.
The grant will support activities including the formulation, development and manufacture of CSX-1004 SQ.
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With only a few approved drugs currently available to treat DN by means other than regulation of blood pressure, innovator products that can treat by targeting other factors such as treatment of dyslipidemia, hypertension, or angiotensin inhibition, among others, is a key area of R&D in the DN space and is likely to pave the way for novel therapies in the near future. However, the treatment landscape is expected to remain unchanged due to limited availability of products in the late-stage pipeline currently.
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