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HSA Charges Man for Trafficking Etomidate Vaporiser Pods

The Health Sciences Authority (HSA) of Singapore has charged a 34-year-old man for allegedly trafficking etomidate vaporiser pods. The charges follow an enforcement operation where HSA seized over 900 tablets, cough syrup, and etomidate-containing vaporiser pods. Stricter penalties for etomidate trafficking are in effect.

HSA Deepens International Partnerships for Biomedical Sector Growth

The Health Sciences Authority (HSA) of Singapore has announced deepened collaborations with Malaysia and Uzbekistan to facilitate access to medicines and medical devices. These partnerships include a formalised Medical Device Regulatory Reliance Programme with Malaysia and a Memorandum of Understanding with Uzbekistan for broader regulatory cooperation.

TGA Issues Infringement Notices for Unlawful Importation and Advertising

The Therapeutic Goods Administration (TGA) has issued 11 infringement notices totaling $43,560 to 6 individuals for alleged unlawful importation of unapproved therapeutic goods and unlawful advertising of prescription-only medicines. These actions underscore the TGA's commitment to protecting public health.

Prime Medic Group Fined for Unlawful Weight Loss Medicine Advertising

The Therapeutic Goods Administration (TGA) has issued infringement notices totaling $23,760 to Prime Medic Group and an individual for allegedly unlawfully advertising prescription-only weight loss medicines. Prime Medic Group paid the fines in January 2026.

TGA Seizes 57,000 Illegal Vaping Goods in NSW Crackdown

The Therapeutic Goods Administration (TGA) in Australia, with law enforcement support, seized over 57,000 illegal vaping products in Burwood, NSW. This action targets the illicit supply of vapes, with significant penalties including fines and imprisonment for non-compliance with the Therapeutic Goods Act 1989.

TGA Seizes Illegal Vapes Sold to Young People

The Therapeutic Goods Administration (TGA) in Australia, with police support, seized illegal vaping products from a store in Inverloch, Victoria, allegedly sold to minors. The TGA is investigating further regulatory action and warns retailers against targeting young people with illicit vapes.

TGA Releases Compliance Principles for 2026-2027 Enforcement

The Therapeutic Goods Administration (TGA) has released its compliance principles for 2026-2027, outlining a refreshed, proactive, and risk-based approach to enforcement for therapeutic goods in Australia. The principles apply across all TGA-regulated areas and will be reviewed every two years.

TGA Safety Alert: Ayurvedic Tablets Contain High Heavy Metals

The Therapeutic Goods Administration (TGA) has issued a safety alert regarding Kumar Kalyan Rasa tablets, an Ayurvedic medicine. Testing revealed extremely high concentrations of heavy metals, including mercury, lead, arsenic, and cadmium, posing serious health risks to consumers, particularly pregnant women and children. The TGA urges consumers to exercise extreme caution with such products.

TGA Safety Alert: Natures Valley Collagen Builder contains undeclared sildenafil

The Therapeutic Goods Administration (TGA) has issued a safety alert regarding Natures Valley Collagen Builder tablets, which were found to contain undeclared sildenafil. Consumers are warned that the product poses a serious health risk and should not be taken.

TGA Safety Advisory: Counterfeit GLP-1 Weight Loss Products

The Therapeutic Goods Administration (TGA) has issued an updated safety advisory regarding counterfeit weight loss products falsely claiming to contain GLP-1 receptor agonists. Laboratory testing confirmed these products contain no active GLP-1 ingredients and are not included in the Australian Register of Therapeutic Goods.

Safety Concerns Over Imported Counterfeit Melatonin Products

The Therapeutic Goods Administration (TGA) has issued a safety advisory regarding imported counterfeit unregistered melatonin products. Laboratory testing revealed significant discrepancies in melatonin content, with some products containing over 400% of the labelled amount and others none at all, posing serious risks to consumers, especially children.

TGA Safety Alert: Counterfeit Botox Vials Continue to be Imported

The Therapeutic Goods Administration (TGA) has issued a safety advisory regarding the continued importation of counterfeit Botox vials into Australia. These products, packaged to appear genuine but confirmed as fake by AbbVie, pose significant public health risks and cannot be legally imported under any circumstances.

Voxzogo (vosoritidum) Packaging Text Error Identified

Swissmedic has identified a packaging text error on Voxzogo (vosoritidum) outer packaging. The incorrect dosage information was printed on specific batches, and affected batches have been identified. The company has issued an information letter detailing the error and corrective actions.

Keppra (Levetiracetam) Syringe Change and Medication Error Risk

Swissmedic and UCB-Pharma AG are issuing a communication regarding a change in the application syringe for Keppra (Levetiracetam) oral solution. A new 5 ml syringe replaces the 3 ml syringe for children aged 6 months to 4 years, requiring healthcare professionals to inform caregivers about the change and proper dosing to prevent medication errors.

Cytosar (cytarabinum) Barcode Expiry Date Discrepancy Alert

Swissmedic has issued a Health Professional Communication regarding a barcode expiry date discrepancy for Cytosar (cytarabinum) 2g/20ml, batch CT32407B. The date encoded in the 2D barcode on the vial label is incorrect and does not match the legible expiry date printed on the vial.

Yttrium Citrate (90Y)-YMM-1 Failed Sterility Test

Swissmedic has issued a communication regarding Citrate d'Yttrium (90Y)-YMM-1, Suspension for Injection, batch Z008. The batch failed its sterility test after incubation. While no immediate patient danger is expected, affected patients require close monitoring.

ANSM Ensures Continuity of Emend 125 mg Oral Suspension for Children

The ANSM has announced measures to ensure the continuity of treatment for children using Emend 125 mg oral suspension due to supply difficulties. Prescribers are advised to reserve the oral suspension for specific pediatric cases and explore alternative formulations for older children and adults. Importations are being arranged to cover demand.

ANSM Warns of Significant Risks from Off-Label Isotretinoin Use

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a warning regarding the off-label promotion and use of isotretinoin-based medications for aesthetic purposes on social media. The agency emphasizes that these drugs are strictly indicated for severe acne and carry significant risks, including psychiatric disorders and birth defects.

ANSM Recalls Risks of Varicose Vein Sclerosing Agents

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a notice recalling the serious cardiovascular risks associated with varicose vein sclerosing agents. The agency emphasizes adherence to recommendations and provides new tutorials for reporting adverse events.

PRAC Recommends EU Market Withdrawal of Levamisole Medicines

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the withdrawal of marketing authorizations for medicines containing levamisole from the EU market. This decision is based on a re-evaluation of safety data, concluding that the risks associated with these drugs outweigh their benefits for treating parasitic worm infections.

Doliprane Suspension Recall Due to Pipette Wear-Off

The French Agency for the Safety of Medicines and Health Products (ANSM) has announced a recall of 27 lots of Doliprane 2.4% oral suspension due to a manufacturing defect causing pipette graduations to wear off. This defect poses a risk of incorrect dosage and potential overdose in infants and young children.

EMA CHMP Meeting Minutes July 2025

The European Medicines Agency (EMA) has published the minutes from the Committee for Medicinal Products for Human Use (CHMP) meeting held from July 21-24, 2025. The document details discussions and opinions on various medicinal products, including initial applications and re-examinations.

EMA CHMP Meeting Agenda February 2026

The European Medicines Agency (EMA) has published the draft agenda for the Committee for Medicinal Products for Human Use (CHMP) meeting scheduled for February 23-26, 2026. The agenda outlines topics for discussion, including pre-authorisation and post-authorisation procedures for various medicinal products.

MHRA Safety Roundup February 2026: Falsified Mounjaro Pens

The MHRA has issued a safety alert regarding falsified Mounjaro KwikPen 15mg pre-filled pens found in the UK. The affected pens, batch number D873576, have faulty mechanisms and should not be supplied or used. Healthcare professionals are advised to quarantine and return affected stock.

Semaglutide Drug Linked to Optic Neuropathy Risk

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding a rare risk of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) associated with semaglutide (Wegovy, Ozempic, Rybelsus). Healthcare professionals are advised to refer patients with sudden vision loss for ophthalmological examination and to consider discontinuing semaglutide if NAION is confirmed.

GLP-1/GIP Agonists: Strengthened Pancreatitis Warnings

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated product information for GLP-1 and dual GLP-1/GIP receptor agonists to strengthen warnings about the risk of severe acute pancreatitis, including necrotising and fatal cases. Healthcare professionals are advised to be vigilant and report suspected adverse reactions.

Chikungunya Vaccine (IXCHIQ) Use Restrictions Updated

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has updated restrictions for the IXCHIQ Chikungunya vaccine following a safety review. The vaccine is no longer indicated for individuals over 60 and is contraindicated for those with hypertension, cardiovascular disease, diabetes, or chronic kidney disease.

Falsified Mounjaro KwikPen 15mg Pens Found in UK

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a notice regarding falsified Mounjaro KwikPen 15mg pre-filled pens found supplied through an online pharmacy. Batch number D873576 is affected, and the pens have a faulty mechanism, posing a safety risk to patients.

Isotretinoin Prescribing Guidance Updated

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated prescribing guidance for isotretinoin, removing the requirement for a second prescriber for patients under 18. New risk minimisation measures, including an updated Acknowledgement of Risk Form, have been introduced to ensure safe prescribing.

NICE Guidance: Pegzilarginase for Arginase-1 Deficiency

NICE has published guidance recommending pegzilarginase (Loargys) for treating arginase-1 deficiency in individuals aged 2 years and over. The guidance includes evidence-based recommendations and details a commercial access agreement for the treatment.

Cerliponase alfa for Neuronal Ceroid Lipofuscinosis Type 2 Guidance

NICE has published updated highly specialised technologies guidance (HST34) on cerliponase alfa (Brineura) for treating neuronal ceroid lipofuscinosis type 2 in children. This guidance replaces previous guidance and confirms that patients already receiving treatment can continue.

NICE Guidance: Leniolisib for PI3K delta syndrome

NICE has published highly specialised technologies guidance on the use of leniolisib (Joenja) for treating activated phosphoinositide 3-kinase delta syndrome in individuals aged 12 and over. The guidance includes evidence-based recommendations and information on commercial arrangements for NHS organisations.

NICE Guidance: Olipudase alfa for Niemann-Pick disease types AB and B

NICE has published highly specialised technologies guidance (HST32) on the use of olipudase alfa (Xenpozyme) for treating Niemann-Pick disease types AB and B. The guidance provides evidence-based recommendations for healthcare professionals and commissioners in the UK.

NICE Guidance: Setmelanotide for Bardet-Biedl Syndrome

The UK's National Institute for Health and Care Excellence (NICE) has published highly specialised technologies guidance on setmelanotide (Imcivree) for treating obesity and hyperphagia in Bardet-Biedl syndrome. The guidance provides evidence-based recommendations for patients aged 6 years and over, with specific criteria for treatment initiation.

Canagliflozin Appraisal Terminated for Type 2 Diabetes in Youth

NICE has terminated the appraisal of canagliflozin (Invokana) for treating type 2 diabetes in individuals aged 10 to 17 years. The appraisal was terminated because the company failed to provide an evidence submission. NICE will review this decision if a submission is made.

NICE Guidance on Bevacizumab for Metastatic Colorectal Cancer (TA1136)

NICE has published updated technology appraisal guidance (TA1136) on the use of bevacizumab (originator and biosimilars) with fluoropyrimidine-based chemotherapy for metastatic colorectal cancer. This guidance replaces previous recommendations and provides evidence-based recommendations for healthcare professionals.

NICE Guidance: Epcoritamab for Follicular Lymphoma

NICE has published technology appraisal guidance (TA1139) recommending epcoritamab (Tepkinly) for treating relapsed or refractory follicular lymphoma in adults after two or more lines of systemic treatment. The guidance outlines evidence-based recommendations for healthcare professionals.

NICE Guidance: Durvalumab for Muscle-Invasive Bladder Cancer

NICE has published technology appraisal guidance (TA1138) recommending durvalumab with gemcitabine and cisplatin for the neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer. The guidance includes information on commercial arrangements and reporting adverse events.

Baloxavir marboxil appraisal terminated for children

NICE has terminated the appraisal of baloxavir marboxil for treating and preventing influenza in children aged 1 to 11 years. The decision was made because the company failed to provide an evidence submission for the technology appraisal.

USP Notice: Revision to Sennosides Tablets Monograph Testing Method

The USP has issued a Notice of Intent to Revise the Sennosides Tablets monograph testing method. This revision aims to align the testing procedure with recent changes made to the general sennosides monograph, using sennosides A and B as marker compounds. The targeted official date for this revision is August 1, 2027.

Adapalene Monograph Revision Proposed for Solubility Issue

The USP Small Molecules 3 Expert Committee intends to revise the Adapalene monograph to address a potential solubility issue in the Organic Impurities test. The proposed changes include allowing a larger volume of tetrahydrofuran for the standard stock solution, introducing a two-table format for retention times, and deleting the Limit of Triethylamine test.

Carbachol Monograph Revision - Assay Criteria

The United States Pharmacopeia (USP) is revising the Carbachol monograph to widen the acceptance criteria for Assay from NMT 99.0%-101.0% to NMT 98.0%-102.0%. This change aims to accommodate FDA-approved products with wider specifications and is targeted for publication on May 29, 2026, with an official date of June 1, 2026.

USP Notice: Revision to Guaifenesin, Pseudoephedrine HCL, Dextromethorphan Capsules Monograph

The United States Pharmacopeia (USP) has issued a notice of intent to revise the monograph for Guaifenesin, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Capsules. The revision aims to update a cross-reference to an omitted monograph and incorporate the full text of a previously official assay procedure.

Dapagliflozin Tablets Monograph Revision Notice

The USP is issuing a notice of intent to revise the Dapagliflozin Tablets monograph, with a targeted official date of June 1, 2026. This revision is being made in response to comments received, aiming to incorporate feedback into the monograph.

FDA Approval of JUBEREQ and OSVYRTI (denosumab-desu)

The FDA has approved Biologic License Application (BLA) 761424 for JUBEREQ and OSVYRTI, both containing the active ingredient denosumab-desu, submitted by ACCORD BIOPHARMA INC. This approval marks the addition of new prescription injectable medications to the market.

FDA Approves ARMLUPEG (Pegfilgrastim-unne) Biosimilar

The FDA has approved ARMLUPEG (pegfilgrastim-unne), a biosimilar drug manufactured by LUPIN LTD. This approval marks the addition of a new biosimilar product to the market, following the FDA's review process.

FDA Approves Ranibizumab-leyk Biosimilar (NUFYMCO)

The FDA has approved the Biologic License Application (BLA) 761473 for NUFYMCO (ranibizumab-leyk) from FORMYCON AG. This approval marks the addition of a new biosimilar product to the market.

FDA Approves Filgrastim-LAHA Biosimilar

The FDA has approved FILKRI (filgrastim-LAHA), a biosimilar product, for ACCORD BIOPHARMA INC. The approval was granted on January 15, 2026, under Biologic License Application (BLA) 761027. This marks the addition of a new biosimilar option to the market.

FDA Authorizes Drugs for New World Screwworm in Dogs and Cats

The FDA has issued two Emergency Use Authorizations (EUAs) for NexGard and NexGard COMBO for the treatment of New World screwworm infestations in dogs and cats, respectively. These EUAs are effective until the HHS Secretary terminates the public health emergency declaration for this pest.

FDA Issues Emergency Use Authorization for Ivomec to Prevent Screwworm in Cattle

The FDA has issued an Emergency Use Authorization (EUA) for Ivomec (ivermectin) injectable solution to prevent New World screwworm infestations in cattle. This authorization allows for over-the-counter use under specific conditions and is effective until the declared emergency is terminated.