Incyte bags Opzelura EC approval for treatment of non-segmental vitiligo
Incyte has secured marketing authorization for Opzelura (ruxolitinib) cream 15mg/g from the European Commission (EC) for non-segmental vitiligo with facial involvement in adults and adolescents, ... Read More
Chinook Therapeutics gets orphan drug status from EC for atrasentan in IgAN
Chinook Therapeutics, a US-based biopharma company, has secured orphan drug designation for atrasentan from the European Commission (EC) for the treatment of primary IgA nephropathy ... Read More
Merck seeks FDA and EMA approvals for V114 pneumococcal conjugate vaccine candidate
V114 pneumococcal conjugate vaccine candidate : Merck has submitted applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval ... Read More
Janssen seeks EMA’s expanded approval for DARZALEX in AL amyloidosis
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) seeking the expanded approval ... Read More
Gilead Sciences announces Veklury EU approval for COVID-19 treatment
Veklury EU approval : Gilead Sciences said that Veklury (remdesivir) has been given conditional marketing authorization from the European Commission as a treatment for SARS-CoV-2 ... Read More
Medivir gets orphan medicinal product designation for MIV-818 for HCC in EU
Swedish biotech company Medivir has secured orphan medicinal product designation from the European Commission for MIV-818 for the treatment of hepatocellular carcinoma (HCC). The orphan ... Read More
Sanofi, Regeneron secure Libtayo EMA approval for a type of skin cancer
Libtayo EMA approval : The European Commission has given conditional approval for Libtayo (cemiplimab) for the treatment of adult patients with metastatic or locally advanced ... Read More
Alexion Pharmaceuticals secures FDA priority review for SOLIRIS in neuromyelitis optica spectrum disorder
Alexion Pharmaceuticals has secured a significant milestone with the FDA granting priority review for its C5 complement inhibitor, SOLIRIS (eculizumab), as a treatment for neuromyelitis ... Read More
Biohaven secures orphan drug status for verdiperstat in MSA treatment
Connecticut-based Biohaven Pharmaceutical has received a significant regulatory boost, with the US FDA granting orphan drug designation for its investigational drug verdiperstat for treating multiple ... Read More
Pfizer, AbbVie settle global IP for Humira biosimilar, paving way for European launch
In a significant step towards expanding biosimilar access, Pfizer and AbbVie have resolved all global intellectual property disputes concerning Pfizer’s proposed biosimilar to AbbVie’s blockbuster ... Read More