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The submission sought accelerated approval and was part of the FDA Commissioner’s National Priority Voucher pilot programme. The CRL for bitopertin EPP affects the regulatory pathway and potential

The move is part of Ampersand’s strategy to establish a trans-Atlantic pharmaceutical development partnership through the Purna and MedPharm alliance. This partnership has the potential to become a

The agreement focuses on expanding Lymphir’s international access via country-specific managed access programmes, where permitted by local regulations. Under the terms, Uniphar will act as the exclusive distributor

The Takeda-Iambic AI drug discovery collaboration will initially focus on projects in oncology and gastrointestinal therapeutic area, as well as that of inflammation. Through this arrangement, Takeda will

Set to open in 2029, the facility will cover approximately 466,000ft² and accommodate 1,000 employees. The centre will connect with other Novartis global research locations in Basel, Switzerland,

This contract enables Apotex to seek marketing authorisation and distribute the product in the country through its branded medicine division, Searchlight Pharma, once regulatory approval is secured. Grünenthal

Under this agreement, Everest Medicines will make potential regulatory and commercial milestone payments of up to 1.04bn yuan ($149m) and an upfront payment of 200m yuan. Furthermore, Micot

The deal grants Genentech exclusive global rights to develop and commercialise the selected RNAi programme. According to the contract, SanegeneBio will manage early development activities while Genentech will

The CHMP recommends the use of niraparib and abiraterone acetate with prednisone or prednisolone (AAP), along with androgen deprivation therapy (ADT), specifically for patients with metastatic hormone-sensitive prostate