FDA Approves Emcitate as First Treatment for MCT8 Deficiency
Egetis’ Emcitate is the first and only approved treatment for MCT8 deficiency, with marketing authorisations in the EU and the US.
Egetis’ Emcitate is the first and only approved treatment for MCT8 deficiency, with marketing authorisations in the EU and the US.
According to court documents, between July 2023 and April 2024, the two Indian nationals allegedly obtained counterfeit Ozempic from unauthorised sources in China and distributed the products in the US.
Seven countries — Angola, Bangladesh, the Democratic Republic of the Congo (DRC), Nigeria, South Sudan, Sudan and Yemen — accounted for around 90% of all reported cholera cases and deaths globally.
Novo Nordisk has licensed HRS-1596, a Phase 1-ready oral GLP-1/GIP dual agonist from Hengrui Pharma, in a deal worth up to $2.6 billion, while new real-world data linked semaglutide 2 mg with a lower risk of major adverse cardiovascular events than switching to tirzepatide
According to Akums, the approval of Colchicine 0.5 mg Tablets marks a first-time-in-India regulatory milestone for this application.
A new treatment option for Parkinson’s Disease: AbbVie expects JUVMO to become available to patients in the US in October 2026.
Under the agreement, DKSH will commercialise four pain medicines on behalf of Grünenthal across eight Asia-Pacific markets and will be responsible for seeking local marketing authorisations.
The FDA approval is based on Phase 3 data, with 42% of adolescent patients with severe alopecia areata receiving Olumiant 4 mg achieving at least 80% scalp hair coverage at Week 36, compared with 5% on placebo.
Novo receives a global licence to use Nanexa’s proprietary ALD-based drug delivery platform for peptide drugs targeting obesity, type 2 diabetes and other cardiometabolic diseases.
The development comes as Zydus continues to expand its portfolio of generic medicines in the US market.