Regeneron receives FDA response letter for aflibercept’s BLA
The letter is based on a continuing assessment of inspection data at a third-party filler. No issues linked to aflibercept’s clinical safety or efficacy, design of the clinical
The letter is based on a continuing assessment of inspection data at a third-party filler. No issues linked to aflibercept’s clinical safety or efficacy, design of the clinical
Intended to treat adult patients, fidanacogene elaparvovec is an investigational therapy that comprises a bio-engineered adeno-associated virus (AAV) capsid and a human coagulation Factor IX (FIX) gene variant.
An oral inhibitor of hypoxia-inducible factor prolyl hydroxylase, daprodustat is intended for usage in adult patients who are on chronic maintenance dialysis. The company is developing the therapy
Ensitrelvir is a COVID antiviral presently approved in Japan and being analysed in clinical trials outside of the country. The sublicence agreements were inked with three generic manufacturing
Former investors such as Matrix Capital Management Company and Alexandria Venture Investments, who took part in the firm’s Series A round, joined the latest fundraise along with new
Bluebird is seeking approval for treating a rare genetic disease, SCD, in patients aged 12 years and above having a history of vaso-occlusive events. A modified form of
Under the deal terms, Lilly will begin a tender offer to purchase all outstanding shares of DICE for an acquisition price of $48 per share in cash, which translates to a total
The NDA was accepted by the regulatory agency for review with a PDUFA target action date set for 17 June 2023. As per the CRL, the regulatory body
With the acquisition, Rosemont will expand its existing portfolio and gain access to the new pipeline of products, providing lifesaving pharmaceuticals across the UK and within overseas markets.
Dubbed Act4Biosimilars Action Plan, the new roadmap has been designed to boost the adoption of global biosimilar products by at least 30% points in more than 30 countries