Pfizer, BioNTech Get CHMP Approval for Omicron KP.2-Adapted Vaccine in EU
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…
Ipsen’s Iqirvo Approved in EU as First New Treatment for PBC in a Decade
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…
Governments Advance Pandemic Agreement for Future Emergency Preparedness
Negotiations on the world’s first agreement to safeguard people from future pandemics, led by the World Health Organization (WHO), made significant strides during the latest round of discussions, which concluded…
Elanco Launches FDA-Approved Zenrelia for Canine Dermatology
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)…
Positive CHMP Opinion Granted to Samsung Bioepis and Biogen for Aflibercept Biosimilar, OPUVIZ
Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) have announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion…
US Approves Sarclisa as First Anti-CD38 Therapy for Non-Transplant Multiple Myeloma Patients
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…
Pfizer and BioNTech Get Favorable CHMP Opinion for Omicron KP.2-Adjusted COVID-19 Vaccine in the EU
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have received a recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines…
Fasenra Receives U.S. Approval for Treating Eosinophilic Granulomatosis with Polyangiitis
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…
FluMist Receives Approval for Self-Administration in the US
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…
Phase III Study Confirms Xofluza Significantly Reduces Influenza Virus Transmission
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from the phase III CENTERSTONE study of Xofluza® (baloxavir marboxil), an antiviral medication, demonstrating a significant reduction in the…
Merck Gets EU CHMP Nod for KEYTRUDA in Two Gynecologic Cancers
Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions recommending…
Positive Phase 1 Results for Personalized Vaccine in Lymphoplasmacytic Lymphoma
A team of researchers from City of Hope® and The University of Texas M.D. Anderson Cancer Center has shared promising safety and efficacy results from a Phase 1 trial involving…