Safety Update: New Sorbitol-Containing IV Remsima Formulation
Key Points: A new liquid infusion formulation of Remsima (infliximab) has been introduced in Europe as a 100 mg and 350 mg concentrate for infusion. Unlike the original powder form, the new concentrate contains sorbitol (45 mg/mL)ema.europa.eu. Because patients with hereditary fructose intolerance (HFI) cannot safely metabolize sorbitol, this formulation must not be given to HFI patientsema.europa.eu. Even […]
Depth Article: Revisiting Hormone Replacement Therapy — A Paradigm Shift in Women’s Health
1. Background: What Changed The U.S. Food & Drug Administration (FDA), in coordination with the U.S. Department of Health & Human Services (HHS), has announced a significant regulatory reconsideration: the move to remove or revise longstanding boxed-(“black box”) warnings on many hormone replacement therapies (HRT) for menopause. U.S. Food and Drug Administration+2Science News+2These warnings have […]
Important Update for Healthcare Professionals: Opella Healthcare France
On 24 October 2025, the pharmaceutical company Opella Healthcare France S.A.S. (on behalf of the product) issued a letter to healthcare professionals notifying of a new contraindication for Phenergan oral formulations (25 mg film-coated tablets and 5 mg/5 ml oral solution). HPRA Assets What’s Changed Why This Matters The new contraindication recognises the risk of […]
Safeguarding Children’s Oral Health: A New Chapter by the U.S. Food and Drug Administration
What’s Happening? On October 31, 2025, the FDA issued a landmark announcement titled “U.S. Food and Drug Administration Acts to Protect Children from Unapproved Fluoride Drug Products”. U.S. Food and Drug Administration+1 The gist of the action is that the FDA is moving to restrict the sale and use of ingestible fluoride prescription drug products […]
Accelerating Biosimilar Development: A Key Move by the FDA
On October 29, 2025, the FDA announced that it is taking major steps to make it faster and less costly to develop biosimilar medicines—the lower-cost alternatives to biologic drugs that treat many serious and chronic diseases. U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2 Specifically, the agency released a draft guidance titled “Scientific Considerations […]
New FDA Draft Guidance: Elevating Safety, Transparency & Testing for Menstrual Products
Introduction In October 2025, the FDA published a draft guidance titled Menstrual Products – Performance Testing and Labeling Recommendations (Draft Guidance for Industry and FDA Staff). U.S. Food and Drug AdministrationThis guidance provides non-binding recommendations for manufacturers of menstrual products (tampons, pads, menstrual cups) regarding performance testing, specification, materials/disclosure, and labeling. U.S. Food and Drug […]
EMA partners with content creators to promote safe and responsible use of GLP-1 medicines
What the announcement says The EMA has launched its first social-media campaign to raise awareness of the safe and responsible use of GLP-1 receptor agonist medicines. European Medicines Agency (EMA)Key points: Why this step is important Several reasons why EMA’s initiative is both timely and significant: For someone in the healthcare or medical-store business (such […]
Research Report — Contaminated Cough Syrups in India (Oct 2025): Scope, Data, Regulatory Response, and Public-Health Implications
Prepared for: Shudarsana Company / Regulatory & Safety StakeholdersDate: 15 October 2025 (content current as of 15 Oct 2025)Sources: FDA, Reuters, WHO-related reporting, RAPS, Chemistry World, Reuters investigative archives, peer-reviewed summaries. Key sources cited inline. Executive summary (key facts & numbers) Background: DEG/EG contamination — why it kills Diethylene glycol (DEG) and ethylene glycol (EG) […]
Rethinking Acetaminophen Use During Pregnancy: What the Latest FDA Announcement Means for Expectant Mothers
IntroductionAcetaminophen (also commonly known by brand names like Tylenol) has long been regarded as the go-to over-the-counter medication for pain relief and fever reduction during pregnancy. It is often considered safer than alternatives such as ibuprofen or aspirin, which carry known fetal risks. However, on September 22, 2025, the U.S. Food and Drug Administration (FDA) […]