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Boehringer partnership to advance biologic for rare skin condition

Boehringer Ingelheim and LEO Pharma have agreed a partnership deal to advance development and commercialisation of the innovative monoclonal antibody Spevigo® (spesolimab). It is the first drug approved for generalised pustular psoriasis flares that specifically targets the IL-36 pathway. It is a rare and potentially life-threatening skin disease, the companies shared.

FDA Issues Final Guidance to Industry, “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products”

U.S. Food and Drug Administration issued a final guidance for industry: “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products.”  The final guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of proposed biosimilar, including …

FDA Issues Final Guidance to Industry, “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products” Read More »

FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma

On July 2, 2025, the Food and Drug Administration granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and …

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FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or …

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FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD

The U.S. Food and Drug Administration (FDA) is revising labeling on all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD), stating that patients younger than 6 years of age taking these medications are at greater risk of weight loss and other side effects compared with older children taking the same medication at the same dosage.