Compounding when Drugs are on FDA’s Drug Shortages List
FDA understands that when a drug is in shortage, patients and health care professionals may look to compounded drugs as…
South Korea’s quintet of alliances for sovereign AI: Kakao notably left out
South Korea is progressing its autonomous AI model development by choosing five key industry alliances—Naver Cloud, SK Telecom, NC AI,…
OpenAI reportedly eyes US$500 billion valuation in employee stock sale
OpenAI is reportedly in talks to allow employees—both current and former—to sell their shares in a deal that could value…
Human Drug Compounding Policies and Rules
List of compounding policy documents and related materials
FDA Responses to Action Items Identified in 2023 Intergovernmental Working Meeting on Drug Compounding
In the most recent Intergovernmental Working Meeting on Drug Compounding, Nov. 7-8, 2023, FDA and state regulators identified three actions…
Neuhaus Issues Allergy Alert on Undeclared Wheat in Belgian Chocolate Moments Smurf’s Popping Milk Chocolates with Cookies’
Neuhaus Chocolates NV of Vlezenbeek, BELGIUM has initiated a voluntary recall for : Belgian Chocolate Moments Smurfs ‘Popping Milk Chocolates…
Zongertinib Approved by FDA for Patients With Nonsquamous NSCLC With HER2 TKD Mutations
The action is supported by positive safety and efficacy findings from the phase 1a/1b first-in-human Beamion LUNG-1 trial.
Compounding Quality Center of Excellence
Compounded drugs pose unique risks to patients because they are not reviewed by the agency for safety, effectiveness or quality.…
FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations
On August 8, 2025, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a…
Intranasal Insulin Shows Promising Brain Uptake Patterns in Alzheimer Disease
Intranasal insulin shows promise in targeting memory regions of the brain, offering new hope for Alzheimer disease treatment in older…