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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, …

FDA Approves First Nonprescription Fixed-Dose Combination of Acetaminophen and Naproxen Sodium for 12-Hour Pain Relief Read More »

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 »

EMA and the European Innovation Council and SMEs Executive Agency (EISMEA) have strengthened their cooperation in support of health innovation in the European Union (EU). Today, EMA’s Executive Director Emer Cooke and EISMEA’s Director Momchil Sabev signed a letter of intent to reinforce their continuing efforts in helping innovators better understand EU regulatory requirements and prepare health …

EMA and EISMEA boost cooperation to accelerate health innovations Read More »