Vertex Pharmaceuticals (Europe) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Kalydeco (ivacaftor) to treat people with cystic fibrosis (CF) aged 12 to <24 months with certain mutations in the CFTR gene.
Kala Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for KPI-121 0.25%, a topical product candidate being developed for the temporary relief of signs and symptoms of dry eye disease.
AstraZeneca and Merck have secured the orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for their poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib) to treat pancreatic cancer.
The US Food and Drug Administration’s (FDA) advisory committee has recommended approval of Celltrion and Teva Pharmaceutical’s biosimilar of Roche’s blood cancer drug Rituxan (rituximab).
Silence Therapeutics has received a notice of intention to grant for a new European divisional patent, EP 3 222 724B, and started a new cross-border interim injunction application in the Netherlands against Alnylam's Onpattro (patisiran).
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Novartis’ new drug application (NDA) and marketing authorization application (MAA) for multiple sclerosis drug siponimod (BAF312).
The US Food and Drug Administration (FDA) has approved Merck’s human papillomavirus (HPV) 9-valent vaccine, Gardasil 9, to be used as treatment for women and men aged from 27 years to 45 years.
Roche has secured approval from the US Food and Drug Administration (FDA) for Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients of all ages having haemophilia A without factor VIII inhibitors.
Shield Therapeutics has submitted a new drug application (NDA) with the US Food and Drug Administration (FDA) for its lead product Feraccru to treat iron deficiency.
Regeneron Pharmaceuticals and Sanofi have secured approval from the US Food and Drug Administration (FDA) for their Libtayo (cemiplimab-rwlc) to treat patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
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