FDA Drugs · Jul 15, 2026
CDER Guidance Agenda
CDER Guidance Agenda
Latest medical news · page 66
The latest headlines across every section, pulled from official and open-access sources.
WHO · Jul 15, 2026
New WHO guidelines: up to 45% of dementia risk could be prevented or delayed
The World Health Organization (WHO) today released updated guidelines on reducing the risk of cognitive decline and dementia , providing countries with evidence-based recommendations to help prevent or delay the onset of dementia across the life course. Dementia is a condition caused by brain diseases and affects memory, thinking and the ability to function. More than 57 million people live with dementia worldwide and nearly 10 million people get newly diagnosed every year. Alzheimer disease is the most common form of dementia and is estimated to account for 60–70% of cases. While there…
UKHSA (UK) · Jul 15, 2026
Official Statistics: Surveillance of bloodstream infections in intensive care units, England: 2025
Annual report and data tables showing how often bloodstream infections occur in critical care in England, the microbes that cause them, and linked factors.
MHRA (UK) · Jul 15, 2026
Guidance: Medical devices: list of UK approved bodies
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
Drugs@FDA · Jul 15, 2026
FDA approves Lipfendra (enlicitide decanoate)
Original new drug approval. tablet, oral. Sponsor: Msd
FDA Enforcement · Jul 15, 2026
Drug recall: Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial
Failed Impurities/Degradation Specifications — ONESOURCE SPECIALTY PHARMA LIMITED · Class II · Ongoing · 4284 vials
FDA Enforcement · Jul 15, 2026
Drug recall: Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L)
Subpotent drug — Gasco Industrial Corp. · Class II · Ongoing · N/A
FDA Enforcement · Jul 15, 2026
Drug recall: Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7…
Subpotent drug — Gasco Industrial Corp. · Class II · Ongoing · N/A
FDA Enforcement · Jul 15, 2026
Drug recall: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL
Subpotent drug — Gasco Industrial Corp. · Class II · Ongoing · N/A
FDA Enforcement · Jul 15, 2026
Drug recall: Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG
cGMP deviations — Shimoga Chemicals · Class II · Ongoing · N/A
FDA Enforcement · Jul 15, 2026
Drug recall: Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only
Lack of Sterility Assurance — Reliance Life Sciences Private Limited · Class II · Ongoing · 5,020 vials
FDA Enforcement · Jul 15, 2026
Drug recall: Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL).
Subpotent drug — Gasco Industrial Corp. · Class II · Ongoing · N/A
FDA Enforcement · Jul 15, 2026
Drug recall: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter)
Subpotent drug — Gasco Industrial Corp. · Class II · Ongoing · N/A
FDA Enforcement · Jul 15, 2026
Drug recall: Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use
Lack of Sterility Assurance — Reliance Life Sciences Private Limited · Class II · Ongoing · 11,400 vials
FDA Enforcement · Jul 15, 2026
Drug recall: Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only
Lack of Sterility Assurance — Reliance Life Sciences Private Limited · Class II · Ongoing · 12,000 vials
FDA Enforcement · Jul 15, 2026
Drug recall: Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and…
Lack of Sterility Assurance — Reliance Life Sciences Private Limited · Class II · Ongoing · 8,001 vials
FDA Enforcement · Jul 15, 2026
Drug recall: Medline Remedy Specialized Silicone Cream (Hydraguard-D )
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. — BioMed Laboratories, LLC. · Class II · Ongoing · 509,652 tubes
FDA Enforcement · Jul 15, 2026
Drug recall: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL
Subpotent drug — Gasco Industrial Corp. · Class II · Ongoing · N/A
FDA Enforcement · Jul 15, 2026
Drug recall: Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL
Failed Impurities/Degradation Specifications — QuVa Pharma, Inc. · Class II · Ongoing · N/A
FDA Enforcement · Jul 15, 2026
Device recall: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Surgical dressing manufactured out of specification (greater thickness). — ConvaTec, Inc · Class II · Ongoing · 4230 units
FDA Enforcement · Jul 15, 2026
Device recall: GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC.…
Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results. — WALLAC OY · Class II · Ongoing · 3,274 units
FDA Enforcement · Jul 15, 2026
Device recall: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
A product error defect may cause incorrect bracket placement. — Klowen Braces · Class II · Ongoing · 3 units
FDA Enforcement · Jul 15, 2026
Device recall: MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or … — Medtronic MiniMed, Inc. · Class II · Ongoing · 778
FDA Enforcement · Jul 15, 2026
Device recall: Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope…
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers. — Olympus Corporation of the Americas · Class II · Ongoing · 988700 units