EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.
EMA’s safety committee (PRAC) has completed its review of Ixchiq (a live attenuated chikungunya vaccine), following reports of serious side effects. The previous temporary restriction on vaccinating people aged 65 years and above, which was put in place during the review, will now be lifted.
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.
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 …
This final guidance describes FDA’s current recommendations on drug development considerations for the treatment of early Lyme disease (i.e., early localized and early disseminated disease), including trial population, trial design, safety, and efficacy among other considerations.
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 …
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 …
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.
