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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 …

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

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 …

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

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.

Gilead Sciences, Inc. and Kymera Therapeutics, Inc have agreed to jointly develop and commercialise a novel molecular glue degrader (MGD) programme targeting cyclin-dependent kinase 2 (CDK2) for oncology indications. The small molecule treatment provides a new mechanism of action. Instead of inhibiting CDK2, which can lead to side effects, the drug removes CDK2 from cells.

The U.S. Food and Drug Administration (FDA) is notifying health care professionals of safety-related changes to the prescribing information for the ileal bile acid transporter (IBAT) inhibitors, Livmarli (maralixibat) and Bylvay (odevixibat). These medications are indicated to treat cholestatic pruritus (persistent itching) in patients with Alagille syndrome (ALGS) or progressive familial intrahepatic cholestasis (PFIC).

FDA announced the availability of final guidance for industry titled Conducting Remote Regulatory Assessments Questions and Answers. The final guidance describes how FDA will use Remote Regulatory Assessments (RRAs) for FDA-regulated products.

Chinese researchers have developed a new method that significantly improves the efficiency and sustainability of beta-blocker (β-blocker) production. Notably, the team achieved rapid, continuous-flow synthesis of propranolol. According to their findings, the innovative amine-functionalised graphene oxide (NGO) membrane reactor enabled nearly 100 percent conversion and selectivity in under 4.63 seconds at 23 °C.

The National Institute for Health and Care Excellence (NICE) has recommended against approving Leqembi (lecanemab) and Kisunla (donanemab) to treat mild cognitive impairment or mild dementia caused by Alzheimer’s, in its final draft guidance.

EMA’s human medicines committee (CHMP) has started a review of medicines containing sodium oxybate used in people with alcohol dependency to treat alcohol withdrawal syndrome and to support long‑term abstinence.

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Zemcelpro (dorocubicel / unexpanded umbilical cord cells) to treat adults with haematological malignancies (blood cell cancers). Zemcelpro can be used in patients requiring an allogeneic haematopoietic stem cell transplantation (allo-HSCT, transplantation of stems cell from a donor) following myeloablative conditioning (chemotherapy …

New stem cell therapy to treat patients with blood cancers Read More »