Drug Approval | January 14, 2026
Camurus’ Oclaiz NDA resubmission accepted by FDA
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition
Agreement enables access of EU-approved treatment for myotonia symptoms in non-dystrophic myotonic disorders to patients from Argentina and Colombia
With this additional route of administration, the MMRV Family now joins other routinely recommended vaccines that can be administered intramuscularly
NDM disorders are a group of rare, inherited neuromuscular disorders with an estimated prevalence of 1 case per 100,000 inhabitants in Spain, and are characterized by the inability to relax muscles following voluntary contraction (myotonia)
The new facility will be able to handle four times as many patients as the previous facility.
NDM disorders are a group of rare, inherited neuromuscular disorders which is characterized by the inability to relax muscles following voluntary contraction
First installation of AI-powered AMULET SOPHINITY at NM Medical aims to strengthen early breast cancer detection
Dual regulatory clearances for Sentire(R) Endoscopic surgical system strengthen the company’s expansion across Europe and Asia-Pacific in minimally invasive robotic surgery
In the new study, scientists at the University of Virginia used gene-editing techniques to modify GLP-1 receptors in mice to make them more humanlike
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