Penumbra’s Indigo System; Axonics’s F15 Recharg...

Sanofi’s Rare Disease Drug Xenpozyme Wins World’s First Approval in Japan Sanofi’s Xenpozyme, also known as olipudase alfa, the world's first therapy for the rare disease Niemann-Pick type A/B and B, has been approved for the treatment of children and adults with non-CNS manifestations of Acid Sphingomyelinase D...

NHS Grants Fast Track Access to Takeda’s Exkivity Takeda has secured UK approval for its lung cancer therapy Exkivity, with an NHS access deal that could see it prescribed to patients within the next few weeks. The Medicines and Healthcare products Regulatory Agency has granted conditional marketing authorisa...

Cannabidiol (CBD) is one of the 120 cannabinoids present naturally in cannabis plants. After tetrahydrocannabinol (THC), Cannabidiol is the second most prevalently available cannabinoid. Cannabidiol, an important component of medicinal marijuana, is either directly from the hemp plant or synthesized in a laboratory...

Bioventus Receives 501(k) Clearance for StimRouter Pain Management Device On March 1, 2022, the US Food and Drug Administration (FDA) gave Bioventus' StimRouter Neuromodulation System 510(k) approval. The next-generation pain treatment device is intended to treat chronic pain caused by peripheral nerves, ex...

GSK’s Covifenz, A Plant-Based COVID Vaccine, Receives First Approval The recombinant COVID-19 vaccine developed by Medicago, now known as Covifenz, has received approval in Canada, the company's home country. Covifenz employs Coronavirus-Like Particle (CoVLP) technology, with the vaccine consisting of recombinan...

Biogen's Aduhelm Marketing and Approval are Under Scrutiny in New FTC and SEC Investigations Biogen can't seem to get a break when it comes to the Alzheimer's disease drug Aduhelm. Along with limited sales and a constraining Medicare coverage plan, the medicine is now facing additional scrutiny as part of a pair...