The date of approval is generally the point in time when a drug is considered eligible for market access. In looking across the past four years of regulatory decisions, we noticed that some of the ...

Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable ...

Arcadium Lithium (ALTM) has now received all required pre-closing regulatory approvals in connection with the proposed acquisition of Arcadium ...

Alnylam awaits FDA decisions on Amvuttra & Fitusiran next month, poised to boost revenue, profitability, and share growth.

Grayscale and NYSE Arca have filed for the first US Cardano ETF, which would hold ADA tokens in cold storage through Coinbase ...

Welcome to Fierce Pharma's regulatory tracker for the first half of 2025. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and ...

Bitcoin and Ethereum got their ETFs, and now Solana and XRP want to be next. But one analyst says Litecoin will come first.

Novo Nordisk said on Wednesday it plan to file its experimental next-generation obesity drug CagriSema for regulatory approval during the first quarter of next year, slightly later than its previous ...

The medicines under these programs are approved faster by regulatory agencies. In addition, in the UK, the launch of The Accelerated Access Collaborative, a government initiative to fast-track ...

The decision from the Civil Aviation Authority (CAA) is the final significant piece of regulatory approval needed for ... to receive a licence for this type of launch. Known as RFA One, the ...