Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for their Omicron KP.2-adapted monovalent COVID-19 vaccine (COMIRNATY® KP.2). This…
Ipsen (Euronext: IPN; ADR: IPSEY) has announced that the European Commission has granted conditional approval for Iqirvo® (elafibranor) 80mg tablets. Iqirvo is approved for the treatment of primary biliary cholangitis (PBC) in adults, either in combination with ursodeoxycholic acid (UDCA)…
Elanco Animal Health Incorporated (NYSE: ELAN) has announced that the U.S. Food and Drug Administration (FDA) has approved Zenrelia™, a once-daily oral JAK inhibitor for the control of pruritus (itching) caused by allergic dermatitis and atopic dermatitis in dogs 12…
The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell…
AstraZeneca’s Fasenra (benralizumab) has received U.S. approval for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare and potentially fatal immune-mediated vasculitis that can damage multiple organs. This approval from the U.S. Food and Drug Administration (FDA) is…
FluMist has become the first self-administered influenza vaccine approved in the US. This needle-free nasal spray can now be self-administered by adults up to 49 years old or given by a parent or caregiver to children aged 2-17. The US…
Glycomine, Inc., a biotechnology company specializing in treatments for rare diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to GLM101, a mannose-1-phosphate replacement therapy being developed to treat phosphomannomutase 2-congenital disorder of…
Novartis announced today that the US Food and Drug Administration (FDA) has approved Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and…
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved OCREVUS ZUNOVO™ (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This new formulation is…
Genentech, part of the Roche Group, has announced that the U.S. Food and Drug Administration (FDA) has approved Ocrevus Zunovo™ (ocrelizumab & hyaluronidase-ocsq) for treating both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus Zunovo is the…
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has granted approval for Dupixent® (dupilumab) as an add-on maintenance therapy for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis…
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs), the first subcutaneous (SC) PD-(L)1 inhibitor for cancer treatment in the United States. This new formulation can be…