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August 20, 2021
The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.
UK's ABPI responds to the latest revisions being made to NICE methods for assessment of drugs and devices.
August 18, 2021
FDA approves Merck’s Welireg for the treatment of adult patients with von Hippel-Lindau disease who require therapy for tumor growth.
WHO’s solidarity plus trial will enroll hospitalized patients to test artesunate, imatinib, and infliximab in hospitalized COVID-19 patients.
BlackBerry’s QNX real-time operating system may create cybersecurity vulnerabilities, according to FDA.
TriRx hosts various leaders at a ribbon-cutting ceremony for their new facility.
BlueAllele has been granted a US patent for its advanced gene-editing technology, PALIDON, which is compatible with existing gene editing nucleases and delivery systems.
August 17, 2021
Thermo Fisher’s manufacturing site in Greenville, NC was recognized for manufacturing excellence.
FDA has granted its first approval for an idiopathic hypersomnia treatment.
August 16, 2021
FDA has opened a public docket soliciting feedback on the regulation process surrounding PANDAs.