Drug Approvals

China’s National Medical Products Administration has granted conditional approval to a new pre-surgery treatment for adults with HER2-positive stage II or III breast cancer. The regimen uses trastuzumab deruxtecan followed by a combination of paclitaxel, trastuzumab, and pertuzumab, marking the first time this drug has been approved globally in the neoadjuvant setting. The decision is […]

The European Medicines Agency has approved a major update for subcutaneous daratumumab, allowing it to become the first cancer injectable in Europe that patients can administer themselves at home. This change means that patients with multiple myeloma, or their caregivers, can give the treatment outside of a hospital starting from the fifth dose, as long

Japan’s Ministry of Health, Labour and Welfare has approved risovalisib for patients with advanced or recurrent ovarian clear cell carcinoma who carry PIK3CA mutations and whose disease has progressed after chemotherapy. The decision offers a new targeted option for a difficult-to-treat form of ovarian cancer. Alongside the drug, the AmoyDx PIK3CA Mutation Detection Kit was

The U.S. Food and Drug Administration has delayed its decision on LNTH-2501, an imaging agent developed by Lantheus for detecting neuroendocrine tumors. The new decision date is June 29, 2026, about three months later than originally planned. The delay was requested to allow more time to review manufacturing details, not because of concerns about safety

The U.S. Food and Drug Administration has updated the label for nadofaragene firadenovec-vncg, a gene therapy used to treat high-risk non–muscle-invasive bladder cancer that no longer responds to standard BCG treatment. The update introduces a faster thawing process using a warm water bath, cutting preparation time to about 25 minutes. This makes it easier for

The U.S. Food and Drug Administration has approved relacorilant in combination with nab-paclitaxel for adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer who have already received one to three prior treatments, including bevacizumab. This approval is based on a phase 3 trial involving 381 patients, where the combination therapy was compared with nab-paclitaxel

The U.S. Food and Drug Administration has approved nivolumab (Opdivo) in combination with chemotherapy (AVD) to treat adults and children aged 12 and older with advanced classical Hodgkin lymphoma who have not received prior treatment. The drug was also fully approved for adults whose disease has returned or not responded after stem cell transplant or

ChemoSeed, a new implantable drug-delivery system, has received Orphan Drug Designation from the FDA for treating aggressive high-grade gliomas, including glioblastoma. Traditional chemotherapy often struggles to reach brain tumors due to the blood-brain barrier. ChemoSeed overcomes this by using tiny biodegradable implants placed directly into the tumor or surgical site. These “seeds” release Irinotecan over

Johnson & Johnson has submitted an application to the European Medicines Agency to expand the use of Teclistamab (Tecvayli) for patients with relapsed or refractory Multiple Myeloma. The request seeks to move the therapy from a fourth-line treatment to a second-line option, allowing patients to receive the immunotherapy earlier in their treatment course. The application

The U.S. Food and Drug Administration has granted traditional approval to teclistamab (Tecvayli) in combination with daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adults with relapsed or refractory Multiple Myeloma who have received at least one prior treatment. The agency also converted teclistamab as a single therapy from accelerated approval to full approval. The decision is