AstraZeneca said on Friday its drug for preventing infant RSV, Beyfortus (nirsevimab), was recommended for approval in the European Union by a European Medicines Agency committee.
Tag Archive for: European Medicines Agency (EMA)
Demand for booster vaccinations against COVID-19 is low in Germany, the association of general practitioners said on Thursday, with some patients waiting for a booster designed to combat the currently circulating Omicron BA.4/5 subvariants.
People in Europe should take whatever COVID-19 booster is available to them in the coming months, Emer Cooke, Executive Director of the European Medicines Agency (EMA), said in a Reuters Next Newsmaker interview, ahead of an expected autumn rise in infections.
The European Medicines Agency (EMA) on Monday recommended a COVID-19 booster designed to combat Omicron offshoots BA.4/5, days after endorsing a pair of boosters tailored to target the older BA.1 variant.
The European Union’s drugs regulator may be a few weeks from deciding whether to approve the experimental COVID-19 vaccine developed by French drugmaker Sanofi and its British partner GSK, a Sanofi executive said on Monday.
The European Union’s drug regulator on Thursday backed two separate COVID-19 vaccine boosters updated to target the Omicron variant, ahead of an anticipated rise in infections this winter.
Omicron-adapted vaccines will be delivered to the European Union within days of regulatory approval, European member of parliament Peter Liese said on Wednesday.
The European Medicines Agency (EMA) will hold an extraordinary meeting on Sept. 1 to discuss applications from Moderna and Pfizer for vaccine boosters modified to target the Omicron variant, the regulator said on Tuesday.
Inhibrx Inc. announced that the European Commission (“EC”), based on a positive opinion issued by the European Medicines Agency (“EMA”), has granted orphan medicinal product designation to INBRX-109 for the treatment of chondrosarcoma.
Spain has asked the European Medicines Agency (EMA) for permission to give more people a smaller dose of monkeypox vaccine, an approach known as “dose sparing” to distribute limited supplies as far as possible, the health ministry said.
