The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tivdak, ( tisotumab vedotin) intended for the… read more.
Eli Lilly and Company announced results from the VIVID-2 open-label extension study, which showed the majority of patients with moderately to severely active Crohn’s disease receiving two years… read more.
AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following… read more.
The FDA has approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb Company) for subcutaneous injection across approved adult, solid tumor nivolumab (Opdivo, Bristol Myers Squibb Company) indications… read more.
Bayer announced the submission of a marketing authorization application to the Ministry of Health, Labour, and Welfare (MHLW) in Japan, seeking approval of finerenone in adult patients with… read more.
Johnson & Johnson announced the submission of two supplemental Biologics License Applications (sBLAs) to the FDA seeking approval of Tremfya (guselkumab) for the treatment of children 6 years… read more.
GSK plc announced that the China National Medical Products Administration has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as an add-on therapy with intranasal corticosteroids… read more.
AbbVie announced that the FDA has approved Emblaveo (aztreonam and avibactam), as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic. It is approved in combination with… read more.
Amgen announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorisation to Imdylltra for the treatment of adult patients with extensive-stage… read more.
Axsome Therapeutics, Inc. announced that the FDA has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. Symbravo represents a novel… read more.
The Medicines and Healthcare products Regulatory Agency (MHRA) (UK) has 16 January 2025, approved the medicine seladelpar (Livdelzi) in adults for the treatment of a liver illness called… read more.
Valneva SE reported further positive Phase III data in adolescents for its single-shot chikungunya virus (Chikv) vaccine, Ixchiq, which showed a sustained 98.3% sero-response rate one-year after single… read more.
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