Today, the U.S. Food and Drug Administration took additional actions as part of the agency’s work to ensure any electronic nicotine delivery system (ENDS) products available for sale have demonstrated that marketing of the products is appropriate for the protection of the public health. What You Need to Know The FDA authorized several tobacco-flavored ENDS products from [...]
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation for Evusheld, developed by AstraZeneca AB, for the prevention of COVID-19 in adults and adolescents from 12 years of age weighing at least 40 kg before potential exposure to the SARS-CoV-2 virus. Evusheld is made of the active substances tixagevimab and cilgavimab, two monoclonal antibodies designed to attach [...]
Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease [...]
Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Jardiance is also approved to [...]
EMA’s human medicines committee (CHMP) has recommended that a booster dose of the COVID-19 vaccine Comirnaty may be given where appropriate to adolescents from 12 years of age. Comirnaty is already authorised in the EU as a 2-dose primary course in adolescents1 (as well as adults and children from 5 years of age) and a booster [...]
EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use in children aged 6 to 11. The vaccine, developed by Moderna, is already approved for use in adults and children aged 12 and above. The dose of Spikevax in children from 6 to 11 years of age [...]
EMA has recommended granting a marketing authorisation in the EU for Breyanzi (lisocabtagene maraleucel), a gene therapy for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), whose cancer has come back or who have not responded to treatment after two or more [...]
EMA’s human medicines committee (CHMP) has approved a scale up of manufacturing of Vaxzevria (previously COVID-19 Vaccine AstraZeneca). An existing manufacturing site operated by Universal Farma in Guadalajara, Spain, will add a second filling line for the finished product. This change is expected to support the continued supply of Vaxzevria, including for donations to third [...]
EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused by the Omicron variant which is now spreading rapidly across the EU. Although Omicron appears to be more infectious than other variants, studies from South Africa, UK and some EU countries show a lower risk of being hospitalised after [...]
A Agência Europeia de Medicamentos (EMA na sigla em inglês) continua a monitorizar os dados sobre a eficácia das vacinas contra a COVID-19, incluindo a doença causada pela variante Omicron. Embora a variante Omicron pareça ser mais infeciosa do que outras variantes, os estudos realizados em alguns países, nomeadamente, África do Sul, Reino Unido e [...]
Dans le contexte d’émergence de nouveaux variants du Covid-19, nous restons mobilisés pour permettre aux patients un accès le plus précoce possible aux traitements innovants. A ce titre, nous avons participé au niveau européen à l'évaluation de la monothérapie par anticorps monoclonal Xevudy (sotrovimab, GSK) qui a obtenu une autorisation de mise sur le marché (AMM) européenne [...]
EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine Paxlovid (PF-07321332 and ritonavir). The applicant is Pfizer Europe MA EEIG. The application is for the treatment of mild-to-moderate COVID 19 in adult and adolescent patients (12 years of age and older weighing at least 40 kg) who are at high [...]
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older. “The country is in the middle [...]
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to: Expand the use of a single booster dose to include use in individuals 12 through 15 years of age. Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster [...]
This new combination treatment is for people with mild to moderate COVID-19 who are at high risk of developing severe COVID-19 A COVID-19 treatment called Paxlovid (PF-07321332 and ritonavir) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to be safe and effective at reducing the risk of [...]
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized [...]
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of [...]
Today, the U.S. Food and Drug Administration authorized marketing of the first laser-based device for the removal of Inferior Vena Cava (IVC) filters. The device is designed for patients who have an IVC filter, a small cage-like device inserted into the largest vein in the body to capture blood clots and prevent them from traveling [...]
Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. La vacuna desarrollada por Novavax previene la enfermedad causada por SARS-CoV-2 en personas a partir de 18 años y es la [...]
Today, the U.S. Food and Drug Administration approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. Apretude is given first as two initiation injections administered one month apart, and then every two [...]