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The vacancy notice for the next EMA Executive Director has been published in the Official Journal of the European Union, marking the beginning of the recruitment process for the most senior role at the Agency. The next Executive Director will take over the position from the current Executive Director, Emer Cooke, whose mandate at the helm of the …

Recruitment procedure opens for next Executive Director of the European Medicines Agency Read More »

EMA’s safety committee (PRAC) recommended that medicines containing levamisole be withdrawn from the EU market. This follows an EU-wide review which concluded that the benefits of these medicines no longer outweigh their risks for the treatment of parasitic worm infections in adults and children.

On February 26, 2026, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.

FDA published a new batch of draft product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating evidence to support abbreviated new drug application (ANDA) approvals. FDA publishes PSGs to help facilitate generic drug development, streamline ANDA assessment, and support greater access to safe, effective, and high-quality treatments. Improving access to generic medicines supports the …

FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development Read More »

On February 23, 2026, the U.S. Food and Drug Administration (FDA) approved Dupixent (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) with a history of sino-nasal surgery or for whom surgery is not advisable. This is the first approval for this condition.

On February 24, 2026, the Food and Drug Administration granted traditional approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-authorized test. Encorafenib received accelerated approval in combination with …

FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation Read More »

The purpose of this guidance is to describe considerations for generating substantial evidence of effectiveness and evidence of safety for individualized therapies based on a plausible mechanism framework. The plausible mechanism framework outlines a set of recommendations to help developers of individualized therapies generate sufficient clinical safety and efficacy data to demonstrate that a drug …

FDA draft guidance Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause Read More »