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news.F2G receives Complete Response Letter for olorofim NDA
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
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
Vasopressin Injection is a generic equivalent to Par Pharmaceutical’s Vasostrict and is available in a single dose vial of 20 units per 1 mL. Fresenius has invested nearly
EP-104IAR has been designed for meeting the market demand for long-lasting disease relief in many indications and gain benefit from highly localised and longer delivery of corticosteroids. It
The partnership will focus on the production of adenoviral vector. Under the collaboration, Curigin will use the capabilities of Charles River in contract development and manufacturing organisation (CDMO)
Comac founder and CEO Dr Milen Vrabevski and its other shareholders will retain a significant minority stake. The companies have not disclosed the financial terms of the deal.
The transaction includes 108 issued and pending patents globally with the latest expiring this year including three Orange Book listed patents. The acquisition will expedite Cosette’s women’s health
Initially, the companies signed a manufacturing agreement in March last year for a Pfizer product. As per the new agreement terms, Samsung Biologics will provide Pfizer with more
Carvykti is intended to treat adults with relapsed or refractory multiple myeloma who have previously received a minimum of one line of therapy including a proteasome inhibitor, an