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On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have …

FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas Read More »

In July 2025, the U.S. Food and Drug Administration (FDA) published the draft guidance “E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials”. The draft guidance, developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), is intended to provide general principles on the conduct …

Public Comments on ICH E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials Are Being Accepted Through September 19, 2025 Read More »

Treatment Can Be Used for At-Home Administration On Aug. 29, the U.S. Food and Drug Administration (FDA) approved Leqembi Iqlik (lecanemab-irmb) subcutaneous (under-the-skin) injection for maintenance treatment of adults with Alzheimer’s disease. Leqembi Iqlik is indicated for patients who have completed at least 18 months of treatment with intravenous (administered into the vein) Leqembi. Leqembi …

FDA Approves Under-the-Skin Form of Drug for Maintenance Treatment of Alzheimer’s Disease Read More »

On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary …

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer Read More »

The US Food and Drug Administration (FDA) is proposing a new procedure for rare disease clinical trials to help expedite their review. The Rare Disease Evidence Principles (RDEP) process is intended to assure trial sponsors that the FDA’s assessments will encompass additional supportive data.

Servier has strengthened its neurology pipeline with the acquisition of a potential treatment for Fragile X syndrome, the most common genetic cause of autism spectrum disorder, struck a deal with Kaerus Bioscience that could be worth $450m to the UK biotech for its oral small molecule KER-0193 should all the deal’s development and commercial milestones be …

Servier acquires treatment for autism genetic cause Fragile X syndrome Read More »

The World Health Organization (WHO) has revised its priority lists for essential medicines, adding drugs for a variety of cancer types and for diabetes with associated comorbidities such as obesity. The new additions to the Model Lists of Essential Medicines (EML) and Essential Medicines for Children (EMLc), which support global policy decisions around selection and …

WHO adds cancer and diabetes drugs to its essential medicines list Read More »

EMA’s safety committee (PRAC) has started a review of medicines containing levamisole, authorised in four countries of the European Union (EU) to treat infections caused by parasitic worms in adults and children. The review follows concerns about a risk of leukoencephalopathy with levamisole, a potentially serious condition that damages the white matter of the brain.

EMA and the Heads of Medicines Agencies (HMA) are warning the public about the growing threat of illegal medicines being advertised and sold online across the European Union (EU). In recent months there has been a sharp rise in the number of illegal medicines marketed as GLP-1 receptor agonists such as semaglutide, liraglutide and tirzepatide …

Warning about sharp rise in illegal medicines sold in the EU Read More »

U.S. Food and Drug Administration issued two final guidances for industry related to biosimilar development. The final guidance “Classification Categories for Certain Supplements Under BsUFA III” provides recommendations for biosimilar manufacturers as well as FDA review staff on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted …

FDA Issues two Biosimilar Final Guidance to Industry, “Classification Categories for Certain Supplements Under BsUFA III” and “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations” Read More »