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Feb 12, 2025
On 12 February 2025, Qyuns Therapeutics Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has accepted the marketing authorisation application and supplemental application for QX001S
Feb 12, 2025
On 12 February 2025, Pfizer announced that the US FDA has approved Adcetris® (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of adult patients with
Feb 12, 2025
On 12 February 2025, UCB announced that two-year data from the BE HEARD trials for Bimzelx® (bimekizumab) demonstrated sustained disease control in patients with moderate to severe
Feb 12, 2025
On 12 February 2025, New Zealand’s Pharmac announced that, from 1 March 2025, it will extend funding of Celltrion’s Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), for
Feb 11, 2025
On 11 February 2025, the Australian Therapeutic Goods Administration (TGA) approved Alovtech and Cipla’s Uteknix®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in two formulations:
Feb 11, 2025
On 11 February 2025, MSD announced that Health Canada has approved Keytruda® (pembrolizumab) for the treatment of adults with resectable Stage
Feb 11, 2025
On 11 February 2025, Regeneron announced that the US FDA has accepted for review its resubmitted Biologics Licence Application (BLA) for linvoseltamab. Linvoseltamab, a BCMAxCD3
Feb 10, 2025
On 10 February 2025, Bio-Thera Solutions announced that it has entered an exclusive US commercialisation and licence agreement with Intas Pharmaceuticals for BAT2506 (golimumab), biosimilar to J&J’s Simponi® and Simponi Aria®.
Feb 10, 2025
On 10 February 2025, Pfizer and Astellas Pharma announced positive results from their Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The trial evaluated the efficacy and safety of
Feb 10, 2025
On 10 February 2025, the Scottish Medicines Consortium (SMC) issued its February 2025 decisions on medicines for reimbursement by NHS Scotland, including accepting three biologics and rejecting
Feb 10, 2025
On 10 February 2025, Bayer announced that it has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for expanded treatment intervals of up to 6 months
Feb 9, 2025
Medical Dialogues reports that Intas Pharmaceuticals has received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its
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