Approvals
The FDA’s approval of Kisqali in combination with an aromatase inhibitor allows Novartis to target patients with earlier breast cancer who are at risk of recurrence.
Friday’s approval comes after a previous rejection in October 2023 due to manufacturing concerns.
Tecentriq Hybreza, which combines Roche’s Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology, is being touted as the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy.
Tremfya’s ulcerative colitis approval on Wednesday comes as Johnson & Johnson’s blockbuster immunotherapy Stelara continues to face growing competition from biosimilars.
With the regulator’s traditional green light in IgA nephropathy, Filspari is up against Novartis’ Fabhalta—which won accelerated approval last month—and Calliditas’ Tarpeyo, which was approved in December 2023.
Unlike Pfizer/BioNTech and Moderna, Novavax does not use mRNA technology for its COVID-19 vaccine, instead opting for a recombinant version of the virus’ spike protein to elicit protection.
Emergent BioSolutions joins Bavarian Nordic on pharma’s frontline in the fight against the ongoing mpox emergency.
Not all licensing deals are successful. Here, BioSpace examines a few noteworthy assets that Big Pharma returned in the last 12 months.
With the FDA’s rejection of Ordspono in March, Monday’s green light from the European Commission marks the first approval worldwide and the first regulatory victory for Regeneron’s bispecific antibody platform.
The regulator on Thursday said the mRNA vaccines, Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax, will better protect against currently circulating variants as COVID continues to surge in many parts of the U.S.
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