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FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices; asks for reports of injuries related these devices
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The new Innovative Licensing and Access Pathway welcomes first investigational products
Developers work with the NHS, the medicines regulator and the UK health technology assessment bodies from the early stages of clinical development, as part of the Innovative Licensing and Access Pathway.
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Advancing Generic Drug Development: Translating Science to Approval 2025 – 10/07/2025
Join us for the 2025 Advancing Generic Drug Development Workshop! FDA experts will demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. -
100 years of protecting patients through biological standards for medicines
The MHRA produces over 95 per cent of the World Health Organization’s (WHO) biological standards.
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FDA approves new treatment for acromegaly, a rare endocrine disorder
The U.S. Food and Drug Administration (FDA) approved Palsonify (paltusotine) tablets to treat adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. -
Health and Natural Beauty USA Corp. – 700187 – 07/28/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Field Safety Notices: 6 October to 10 October 2025
List of Field Safety Notices from 6 October to 10 October 2025.
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Dr Nicola Rose: A new antibiotic is positive news – but it will take more to stay ahead of superbugs
The MHRA’s Interim Executive Director of Science and Research writes in The British Medical Journal on the approval of the UK’s first new UTI antibiotic in nearly 30 years, and the wider challenge of tackling antibiotic resistance.
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Raw Bistro Pet Fare Voluntarily Recalls Frozen Beef Entrée Because of Possible Salmonella Health Risk
October 9, 2025 – Raw Bistro Pet Fare, Cannon Falls, MN is voluntarily recalling two product sizes of its frozen beef dog food because they may be contaminated with Salmonella. -
FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)
The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI. -
Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed
Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller -
MHRA and NICE invite early adopters to trial accelerated aligned pathway – six months ahead of schedule
Aligned pathway will streamline decisions on licensing and value for medicines, helping patients to benefit from them sooner.
