FDA is launching the Drug Supply Chain Security Act (DSCSA) Assessment of Small Dispensers. This assessment is designed to evaluate small dispensers’ ability to conduct interoperable tracing of product at the package level.
EMA’s Head of the Stakeholders and Communication Division Melanie Carr has been assigned Deputy Executive Director duties as of 1 August 2026. Since 2021, this role has been held by Ivo Claassen, Head of the Veterinary Medicines DiEMA’s Head of the Stakeholders and Communication Division Melanie Carr has been assigned Deputy Executive Director duties as …
On August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
FDA Center for Drug Evaluation and Research (CDER), in partnership with the CDER Quantitative Medicine Center of Excellence, announced a request for information regarding a new collaborative ecosystem for quantitative medicine: the Quantitative Medicine Innovation Network (QMIN).
EMA has recommended granting a marketing authorisation in the European Union for Susvimo (ranibizumab) to treat adults with neovascular (wet) age-related macular degeneration (nAMD). It is for use only in combination with a refillable implant surgically inserted into the eye in people whose disease is stable after responding to intravitreal treatment with a vascular endothelial growth factor …
New treatment option for neovascular age-related macular degeneration Read More »
EMA has recommended granting a marketing authorisation in the European Union for Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and in adolescents from 12 years of age weighing at least 40 kg.
On July 24, FDA approved Tylenol with Naproxen (acetaminophen 325 mg/naproxen sodium 110 mg tablets), the first fixed-dose combination product to pair acetaminophen with naproxen sodium in a single combination tablet for up to 12 hours of pain relief. This nonprescription product is indicated for the temporary relief of minor aches and pains due to headache, backache, …
On July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROn July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1-positive non-small cell …
FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer Read More »
