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FDA grants Orphan Drug Designation to Inhibikase’s Risvodetinib in MSA
Risvodetinib is a chronically administered oral drug candidate that targets the underlying biological mechanism of Parkinson’s disease with an intention to halt the disease progression and reverse the functional loss
Sanguina Announces U.S. FDA-Clearance for AnemoCheck Home
AnemoCheck Home is the only FDA-cleared home anemia test with instant results
Eton Pharmaceuticals Announces Acquisition of FDA-Approved Ultra-Rare Disease Product Nitisinone
The program is designed to help patients access treatment, providing prescription fulfillment services, insurance benefits investigation, educational support, and help in obtaining financial assistance for qualified patients, among other services
WHO’s advisory group recommends Takeda’s Qdenga vaccine for dengue
The United Nations’ health agency will consider the SAGE’s recommendation and revise its position paper on dengue vaccines to include final guidance on Qdenga’s use in public vaccination campaigns
FDA Authorizes Updated Novavax COVID-19 Vaccine Formulated to Better Protect Against Currently Circulating Variants
The updated vaccine addresses currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death
American pharma company Viatris to sell certain businesses for $3.4bn
The drugmaker has received offer for its OTC business, and has agreed to divest its women’s healthcare business, its API business in India, and commercialisation rights in few non-core markets
UK’s MHRA approves Jemperli with chemotherapy in endometrial cancer treatment
GSK’s Jemperli plus chemotherapy is now approved for patients with a tumour abnormality called mismatch repair deficient / microsatellite instability-high by slowing the progression of the disease
Novo Nordisk’s Rivfloza secures FDA nod for adults, children with PH1
The approval was supported by the positive findings from the Phase 2 PHYOX 2 clinical trial and interim data from the ongoing Phase 3 PHYOX 3 extension trial
SGC, HitGen collaborate on DEL technology for drug discovery
HitGen will leverage its DNA-encoded library (DEL) technology platform for the collaboration, specifically the OpenDEL solution, a self-service DEL kit with more than three billion compounds, to screen the under-represented targets selected by SGC
Amicus gets FDA approval for Pombiliti + Opfolda to treat Pompe disease
The FDA has cleared the muscle disorder therapy only for adult LOPD patients whose weight is ≥40kg and who are not improving on their current enzyme replacement therapy