Searching for "approvals" found 32

Global 2023 was a breakthrough year for cell and gene therapies. The field saw a record number of FDA approvals, as other promising therapies in a broad range of therapeutic areas progressed through the pipeline. 2024 looks to be another important year with up to 17 new therapies poised for regulatory…

China In 2023, the first full year after the COVID-19 pandemic, the National Medical Products Administration (NMPA) set a new record by approving the highest number of new drugs in China in a single year, write Chunrong Yu of Gracell Biotechnologies and Xu Wang of Novo Nordisk (China) Pharmaceuticals in the…

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…

Global The Alliance for Regenerative Medicine (ARM) brands itself as the leading international advocacy organization championing the benefits of engineered cell therapies and genetic medicines for patients, healthcare systems, and society. ARM’s latest sector snapshot details the cell and gene therapy approvals list for 2022, as well as the number of…

India Top stories from Indian pharma including Sanofi India’s plans to demerge its healthcare businesses; Junshi Biosciences and Dr. Reddy’s anti-PD-1 monoclonal antibody partnership; Venus Remedies’ new oncology approvals; CORONA and Ferring’s maternal health agreement and Ipca Laboratories and Sun Pharma’s quality issues.   Zydus Lifesciences reports smallest profit in 14…

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.…

USA An up-to-date list of the US FDA’s Center for Biologics Evaluation & Research (CBER)’s biological license application approvals for 2022. There were nine such approvals in 2022, down from 13 in 2021. For the list of non-biological approvals from the FDA’s Center for Drug Evaluation & Research (CDER), click here.…

Japan An overview of the new medicines approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) between April and November 2022. See the 2021 data here and the full PMDA approval archive here. Hecho conVisme Infographic Maker

USA A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)’s new drug therapy approvals for 2022. CDER approved 37 new drugs in 2022, down from 50 in 2021, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics…

Global After gaining its first global approval in Indonesia, Takeda’s dengue fever vaccine, Qdenga, recently got a green light from the European Commission (EC) to market the vaccine in Europe, laying the foundation for further approvals in dengue-endemic regions like Latin America. We are one step closer to achieving our aspiration…

UK National Health Service (NHS) England CEO Amanda Pritchard has raised concerns about the state of British healthcare in recent weeks and months, proclaiming that the NHS is in a worse place today than in the early days of the COVID-19 pandemic and that pressures on hospitals, maternity care and services…