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Kisqali Tablets: Updated Storage Conditions and Shelf Life

Novartis Pharma GmbH has updated the storage conditions and shelf life for Kisqali 200 mg film-coated tablets. The medicine no longer requires refrigeration and now has an authorized shelf life of 2 years. This information letter was issued by the BfArM.

Health Product Shortages in Canada: 2024-2025 Review

Health Canada has released its review of health product shortages for the 2024-2025 fiscal year. The report details drug and medical device shortages, including reporting requirements for manufacturers and highlights of high-impact cases. It notes a decrease in new drug shortage reports compared to the previous year.

WHO Expert Committee on Pharmaceutical Preparations Meeting

The World Health Organization (WHO) announced the Sixtieth meeting of the Expert Committee on Specifications for Pharmaceutical Preparations, scheduled for October 12-16, 2026. This committee advises the Director-General on medicine quality assurance and the maintenance of The International Pharmacopoeia.

WHO Expert Committee on Biological Standardization Eightieth Report

The World Health Organization has published the eightieth report of its Expert Committee on Biological Standardization. This report details the proceedings and recommendations from the committee's meeting held in October 2024, focusing on the norms and standards for biological products.

FDA Drug Shortage Update

The FDA has updated its list of current and resolved drug shortages. The notice indicates 56 drugs are currently in shortage, 45 have been resolved, and 11 have been discontinued. This update provides a snapshot of the ongoing drug supply situation.

FDA Report on Drug Shortage Prevention Efforts

The FDA has released its annual report to Congress detailing efforts in calendar year 2024 to prevent and mitigate drug shortages. The report highlights successful interventions that prevented 283 potential shortages, with only 15 new shortages identified.

FDA Approves 5 New Novel Drugs in 2026

The FDA has announced the approval of five new novel drugs in 2026 for various medical conditions. These approvals include treatments for achondroplasia, hyperarginemia, schizophrenia, bipolar disorder, atopic dermatitis, and Menkes disease. The agency updated its list of novel drug therapy approvals.

FDA Novel Drug Approvals 2025

The FDA's Center for Drug Evaluation and Research (CDER) approved 46 novel drugs in 2025, meaning they were new and never before marketed in the U.S. The agency has released a report detailing these approvals, including drug names, active ingredients, and their approved uses.

FDA Novel Drug Approvals 2024

The FDA's Center for Drug Evaluation and Research (CDER) approved 50 novel drugs in 2024, representing new molecular entities never before marketed in the U.S. This notice provides a list of these approvals and links to detailed reports and drug information.

FDA Novel Drug Approvals in 2023

The FDA's Center for Drug Evaluation and Research (CDER) approved 55 novel drugs in 2023, representing new therapies not previously marketed in the U.S. The agency released a report detailing these approvals and their uses.