Menarini Group and Radius Health submit new drug application to the U.S. FDA for Elacestrant

June 25, 2022 The Menarini Group and Radius Health announced that Menarini, with support from Radius, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer.

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EMA grants conditional marketing authorisation for first gene therapy to treat severe haemophilia A

Menarini Group and Radius Health submit new drug application to the U.S. FDA for Elacestrant

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EMA grants conditional marketing authorisation for first gene therapy to treat severe haemophilia A

June 25, 2022 EMA has recommended granting a conditional marketing authorisation in the European Union for Roctavian (valoctocogene roxaparvovec) for the treatment of severe haemophilia A in adults who do not have factor VIII inhibitors (auto-antibodies produced by the immune system which make factor VIII medicines less effective) and no antibodies to adeno-associated virus serotype 5 (AAV5).

Scientists find surprising link between immune system, hair growth

June 24, 2022 Salk scientists have uncovered an unexpected molecular target of a common treatment for alopecia, a condition in which a person's immune system attacks their own hair follicles, causing hair loss.

EMA recommends Valneva’s COVID-19 vaccine for authorisation in EU

June 24, 2022 EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in the primary vaccination of people from 18 to 50 years of age.

First case of monkeypox identified in South Africa

June 24, 2022 The first case of monkeypox in South Africa has been confirmed, Health Minister, Dr Joe Phaahla, said during a media briefing in Pretoria.

Finland recommends 5th dose of coronavirus vaccine for severely immunodeficient

June 24, 2022 The Finnish Institute for Health and Welfare (THL) recommends new booster doses for those aged 12 or over whose immune system is severely weakened.

EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17

June 24, 2022 EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use in adolescents aged 12 to 17 years.

Croatia reports first monkeypox case

June 24, 2022 The first case of monkeypox has been confirmed in Croatia, it was confirmed to Croatia Radio Television (HRT) from the Clinic for Infectious Diseases "Dr. Fran Mihaljević" in Zagreb.

Monkeypox vaccine to be offered more widely to help control outbreak in UK

June 23, 2022 UK Health Security Agency published new guidance on offering the Imvanex vaccine to men considered to be at higher risk of exposure.

Novartis lung cancer drug Tabrecta gets EU approval

June 23, 2022 Novartis announced that the European Commission approved Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.