On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Velsipity, intended for the treatment of ulcerative colitis. The applicant for this medicinal product is Pfizer Europe. Velsipity will be available as a 2 mg film-coated tablet. The active substance of Velsipity […]
The CHMP has recommended granting a marketing authorization for Pfizer’s Abrysvo (bivalent, recombinant), a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is the first RSV vaccine indicated for passive immunization of infants from birth through six months of age following administration of the vaccine to the mother during pregnancy. It is also indicated for […]
A Kaiser Permanente study confirms the benefit of nirmatrelvir-ritonavir, also known as Paxlovid, as an early-stage treatment to prevent hospitalization for people with mild to moderate COVID-19, regardless of prior immunity or age. The study was published March 15, 2023, in Lancet ID. “Among Kaiser Permanente members in Southern California who tested positive for coronavirus infection, receiving Paxlovid within 5 […]
China’s medical products regulator has given conditional approval for Pfizer’s COVID-19 drug Paxlovid, making it the first oral pill specifically developed to treat the disease cleared in the country. The National Medical Products Administration said Paxlovid is approved to treat adults who have mild to moderate COVID-19 and high risk of progressing to a severe condition. Further study on the […]
Pfizer and OPKO Health announced that the European Commission has granted marketing authorization for the next-generation long-acting recombinant human growth hormone Ngenla (somatrogon), a once-weekly injection to treat children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone. Ngenla provides pediatric patients, their caregivers and healthcare providers with a new treatment option […]
For at least six months after COVID-19 vaccination, antibodies produced by immune cells become steadily more formidable and more precisely targeted against the virus that causes COVID-19, according to a study of the antibody response to the Pfizer-BioNTech vaccine by researchers at Washington University School of Medicine in St. Louis. The idea that antibodies increase in quality as they decrease […]
Pfizer announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the 100 mg and 200 mg doses of Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for marketing authorization to treat moderate to severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. The […]
Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as 5 to <12 years). For this age group, the vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart. The 10-µg dose level was […]
Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts […]
Pfizer Inc. announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Great Britain marketing authorization for Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and over, who are candidates for systemic therapy. Abrocitinib is licensed in Great […]
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