Tagged with Approvals

Switzerland For the Swiss Agency for Therapeutic Products (Swissmedic), one of the world’s leading regulatory authorities, 2023 was an important year. Not only did the agency gain recognition from the World Health Organisation (WHO), Swissmedic also saw a Good Manufacturing Practice (GMP) agreement between Switzerland and the US FDA come into…

Europe The European Medicines Agency (EMA) recommended 77 drugs for marketing authorisation in 2023, including 39 new active substances, coming up behind the FDA’s record 55 new drug approvals last year. Cancer led the roster of EMA green lights with 25 authorisations, including nine therapies the agency has discerned as major…

USA The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) approved no less than 55 new drugs in 2023, a number surpassing that of 2022 by almost 50 percent. While 28 rare disease treatments and five novel gene therapies got the green light, the agency also…

Europe The European Medicines Agency (EMA) recently published its annual Human Medicines Highlights report, documenting key figures on its recommendations for the authorisation of new medicines in 2022. The Agency gave 89 positive opinions last year and recommended the authorisation of 41 new active substances. See below for a full list.…

Indonesia Takeda gets a first approval for QDENGA, its dengue vaccine, which has been given the green light by the Indonesian National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM), making it the only dengue vaccine approved in the country for use in individuals aged 6 to…

China Writing in the May edition of DIA’s Global Forum magazine, Xu Wang of Novo Nordisk China looks at the new drug approvals in China in 2021. Among other highlights, the approval of two CAR-T products signal that CAR-T treatment has finally entered the commercialization stage. The number of new drug…

USA Pfizer and MSD recently became the latest companies to have COVID-19 treatments authorised by either the US FDA or EMA. Their oral antiviral drugs joined several monoclonal antibodies and others on the list of options available to patients in Europe and the United States. Here is an updated list of…

Japan Following on from our recent compilations of 2020 new drug approvals in the USA, China, and Switzerland, see below for the Japanese PMDA’s new drug approvals list for April-October 2020. Made with Visme Infographic Maker  

Japan A comprehensive list of the new drugs approved by Japan’s Pharmaceutical and Medical Devices Agency (PMDA) in 2019. Made with Visme Infographic Maker  

USA In 2019, the US FDA’s Center for Drug Evaluation and Research approved 42 novel drugs, down from 59 drugs approved in 2018. Novartis had four drugs approved, the highest number from any single pharma company. 16 of the 42, or 38 per cent, received orphan drug designation. This listing does…

USA 59 novel drugs were approved in the USA in 2018, representing a leap from the 46 approved in 2017 and 22 approved in 2016. 19 of the 59 drugs (32 percent) have been designated ‘first-in-class’ and 34 of the 59 drugs (58 percent) were approved to treat rare or “orphan”…

Canada In total there were 27 new active substances (NASs) approved in Canada in 2018, 18 prescription pharmaceutical drugs and 9 biologics. In terms of companies that saw particular success last year, Merck (MSD outside of the US and Canada) had three prescription drugs approved, as did Swiss-headquartered Vifor Pharma. Global…