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2,367 changes Pharma & Drug Safety

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Iowa Board of Pharmacy Adopts UMPJE Exam, Updates PMP Access

The Iowa Board of Pharmacy announced the adoption of the Uniform Multistate Pharmacy Jurisprudence Exam (UMPJE) effective April 1, 2026, and updated access policies for its Prescription Management Program (PMP). Pharmacist access to the Rx Management tool is now restricted to those with a DEA registration number, and data submissions missing a prescriber's DEA number will be flagged as errors.

Priority review Notice Pharmaceuticals
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Kansas Pharmacy Technician Renewal Deadline and Requirements

The Kansas Board of Pharmacy has issued a newsletter reminding pharmacy technicians of the October 31, 2025 renewal deadline. Technicians must complete 20 hours of continuing education and can request a six-month extension if they cannot pass the certification exam by the deadline. Failure to renew will result in registration cancellation and requires a new application process.

Priority review Notice Healthcare
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KS Boards of Pharmacy and Healing Arts Joint Statement on IV Therapy Clinics

The Kansas Boards of Pharmacy and Healing Arts have issued a joint statement addressing concerns about patient safety and regulatory compliance in retail IV therapy clinics. The statement clarifies that IV therapy is a medical practice requiring licensed professionals and outlines the Boards' investigative and referral processes for complaints.

Priority review Guidance Healthcare
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Kansas Adopts Uniform MPJE for Pharmacist Licensure

The Kansas Board of Pharmacy has adopted the Uniform Multistate Pharmacy Jurisprudence Examination (MPJE) for pharmacist licensure, effective April 1, 2026. New graduates and pharmacists transferring licenses will be required to pass the Uniform MPJE, with the previous Kansas MPJE being discontinued at the end of 2026.

Priority review Rule Healthcare
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KS Board of Pharmacy: Proposed Regulation Changes and Updates

The Kansas Board of Pharmacy is proposing changes to administrative regulations, including K.A.R. 68-5-17 and 68-7-26, and revoking K.A.R. 68-1-1a. The newsletter also reminds pharmacists and technicians about free CE on PMP data integrity and requests feedback on USP <797> and <795> adoption.

Priority review Consultation Healthcare
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Kansas Board of Pharmacy Named 2025 Wellbeing First Champion

The Kansas Board of Pharmacy has been recognized as a 2025 Wellbeing First Champion for removing stigmatizing language from its licensing and renewal applications related to mental health. The Board is also initiating a stakeholder process to solicit feedback on its rules and regulations, with submissions due by October 31, 2025.

Routine Notice Healthcare
22d ago FDA Press Releases
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FDA Approves Avlayah for Neurologic Manifestations of Hunter Syndrome

The FDA has approved Avlayah (tividenofusp alfa-eknm) for the treatment of neurologic manifestations of Hunter syndrome in certain pediatric patients. This marks the first drug approval specifically targeting the neurological complications of this rare genetic disorder.

Priority review Enforcement Pharmaceuticals
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Health Canada Seizes Unauthorized Counterfeit Health Products in Mississauga

Health Canada issued a public advisory regarding the seizure of unauthorized and counterfeit health products, including prescription drugs and injectables, from a Mississauga location. These products have not been assessed for safety, efficacy, or quality and pose serious health risks.

Urgent Notice Healthcare
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Famodine Tablet 20mg Recalled Due to Assay Test Result

The Health Sciences Authority (HSA) Singapore has initiated a retail-level recall of Famodine Tablet 20mg (famotidine) due to out-of-specification assay test results. The affected batch (232218) must be stopped from supply and returned to the company.

Priority review Enforcement Pharmaceuticals
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Texas Board of Pharmacy Newsletter - March 2026

The Texas Board of Pharmacy has issued its March 2026 newsletter, providing updates on continuing education requirements, the Prescription Drug Monitoring Program (PMP), scam alerts, and licensing information. The newsletter also includes details regarding an upcoming board meeting.

Routine Notice Healthcare
22d ago WHO News
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WHO HRP Receives $7.2M Funding Commitment for Sexual and Reproductive Rights

The Children's Investment Fund Foundation (CIFF) has committed US$ 7.2 million to the WHO's HRP programme for research in human reproduction. This funding aims to advance sexual and reproductive health and rights globally, particularly in light of cuts to development assistance.

Priority review Notice Public Health
22d ago WHO News
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WHO Guidance on Institutionalizing Health Emergency Simulation Exercises

The WHO has released new global guidance to help countries establish National Health Simulation Exercise Programmes (NHSEP). This guidance encourages a shift from ad-hoc drills to structured, government-led programs for testing and strengthening health emergency preparedness.

Priority review Guidance Public Health
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B. Braun Medical Inc. Urgent Correction for Hemodialysis Bloodlines

B. Braun Medical Inc. issued an urgent medical device correction for specific hemodialysis bloodlines due to the potential formation of air bubbles. The FDA is issuing an Early Alert to notify the public and advise healthcare providers to use alternate equipment or follow specific mitigation steps if the affected devices must be used.

Urgent Enforcement Medical Devices
22d ago ANSM France News
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ANSM Suspends Institut Georges Lopez, Recalls Celsior Lots

The French ANSM has suspended the manufacturing authorization for Institut Georges Lopez (IGL) and recalled all lots of its organ preservation solution, Celsior, produced since March 2024 due to serious manufacturing non-conformities posing a high risk of microbiological contamination. An update on March 25, 2026, indicates IGL has come into compliance, and its manufacturing authorization has been reinstated.

Urgent Enforcement Pharmaceuticals
22d ago ANSM France News
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Rivaroxaban Viatris Lot Recalled Due to Quetiapine Contamination

The French ANSM has ordered a recall of a specific lot (8212020) of Rivaroxaban Viatris 20mg tablets due to cross-contamination with quetiapine. Patients holding this lot are advised to return it to pharmacies for exchange.

Urgent Enforcement Pharmaceuticals
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Rivaroxaban Viatris 20 mg tablet safety information

The French National Agency for the Safety of Medicines and Health Products (ANSM) has issued safety information regarding Rivaroxaban Viatris 20 mg tablets. This alert highlights specific safety considerations and potential risks associated with the use of this medication.

Priority review Notice Pharmaceuticals
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ANSM Safety Information for Pre-analytical Tube

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety recall (R2607993) for the Vacuette CTAD 3.5ml pre-analytical tube manufactured by Greiner Bio-One. Affected medical laboratories have been notified directly by the manufacturer.

Priority review Notice Healthcare
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ANSM Safety Alert: Radius VSM ECG Electrodes and Blood Pressure Cuffs

The French ANSM has issued a safety alert regarding a lot recall of Radius VSM ECG electrodes and blood pressure cuffs by Masimo Corporation. This action is registered under recall number R2607611 and is directed at pharmacies and healthcare facilities.

Priority review Enforcement Medical Devices
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ANSM Drug & Device Safety Alert: Recall of Anti-Ig M-PER Reagent

The French ANSM has announced a recall of a specific lot of the Anti-Ig M-PER reagent used in Hydragel kits by Sebia. This safety action, registered under number R2607839, is intended for medical biology analysis laboratories.

Priority review Enforcement Healthcare
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Navajo Heating Pad Recalled for Overheating and Burn Risk

The FDA has identified a Class I recall for Navajo Manufacturing Company's Handy Solutions Neck & Shoulders Heating Pad (Model 25607) due to an overheating and burn risk. The company is removing the affected devices from the market, and consumers are advised to immediately discontinue use, cut the power cord, and dispose of the product.

Urgent Enforcement Product Safety
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Amneal Pharmaceuticals Recalls Magnesium Sulfate Due to Product Mix-Up

Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, due to a product mix-up where a pouch contained an IV bag of Tranexamic Acid. The recall is to the hospital level nationwide. The company has received no adverse event reports related to this recall.

Urgent Enforcement Pharmaceuticals
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Erbe USA Recalls Flexible Cryoprobes Due to Injury or Death Risk

Erbe USA is recalling flexible cryoprobes due to a risk of serious injury or death from device rupture during activation. The FDA has identified this as the most serious type of recall. Customers are instructed to discontinue use, remove, and quarantine affected devices.

Urgent Enforcement Medical Devices
22d ago DEA Press Releases
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DEA Seattle Seizes 880lbs THC Vape Oil and Processing Equipment

The DEA Seattle Division announced the seizure of 880lbs of THC vape oil, 760lbs of processed marijuana, and a machine capable of filling 4,000 vape cartridges per hour. The owner was found to be shipping these products illegally, indicating a significant bust in illicit cannabis operations.

Priority review Enforcement Consumer Protection
22d ago DEA Press Releases
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DEA Houston Seizes Drugs and Firearms from Apartment

The DEA Houston Division, with assistance from local law enforcement, seized approximately 40 lbs. of methamphetamine, 20 grams of fentanyl, cocaine, over 100 lbs. of marijuana, and 17 firearms from a Southeast Houston apartment. This action highlights ongoing efforts to combat drug trafficking and illegal firearm possession.

Urgent Enforcement Criminal Justice
22d ago DEA Press Releases
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DEA Diversion Control Division Industry Day on IT Modernization

The DEA announced an upcoming Industry Day on March 26, 2026, focused on IT modernization efforts supporting its Diversion Control mission. The event aims to discuss regulatory, legal, compliance, and enforcement missions.

Routine Notice Healthcare
22d ago FDA Warning Letters
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FDA Warning Letter to ImmunityBio Inc. Regarding ANKTIVA®

The FDA issued a warning letter to ImmunityBio Inc. concerning promotional communications for its drug ANKTIVA®. The FDA determined that a direct-to-consumer broadcast advertisement and a podcast were false or misleading, misbranding the drug and violating the Federal Food, Drug, and Cosmetic Act. The agency expressed concern that these communications create a misleading impression that ANKTIVA can cure or prevent all cancer.

Urgent Enforcement Pharmaceuticals
22d ago FDA Warning Letters
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FDA Warning Letter to 4U Health for Adulterated Biologics

The FDA issued a warning letter to 4U Health for distributing an unapproved HIV serological diagnostic dried blood spot self-collection kit. The kit is considered adulterated and misbranded because it lacks the required premarket approval or investigational device exemption.

Urgent Enforcement Healthcare
22d ago FDA Warning Letters
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FDA Warning Letter to Matesbrand.com for Nicotine Pouches

The FDA issued a warning letter to matesbrand.com for illegally marketing new tobacco products, specifically nicotine pouches, without required premarket authorization. The agency determined that the listed nicotine pouch products are adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.

Urgent Enforcement Pharmaceuticals
22d ago FDA Warning Letters
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FDA Warning Letter to Yangzhou H&R Plastic Daily Chemical Co., Ltd.

The FDA issued a warning letter to Yangzhou H&R Plastic Daily Chemical Co., Ltd. following an inspection that revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations. The company failed to adequately test drug products for identity and strength before release and did not properly test incoming components.

Urgent Enforcement Pharmaceuticals
22d ago FDA Warning Letters
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FDA Warning Letter to Longhorn Vaccines and Diagnostics LLC

The FDA issued a warning letter to Longhorn Vaccines and Diagnostics LLC regarding violations of the Quality System Regulation for their PrimeStore® MTM device. The inspection revealed that the devices are adulterated due to inadequate complaint file maintenance and failure to establish proper complaint handling procedures, including evaluating complaints for medical device reporting.

Urgent Enforcement Healthcare
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USPTO Patent Granted for MUC1 Antibodies for Cancer Treatment

The USPTO has granted patent US12583927B2 to Minerva Biotechnologies Corporation for MUC1 antibodies designed for cancer treatment. The patent covers antibodies that specifically bind to the PSMGFR peptide or its fragments, offering potential new diagnostic and therapeutic applications.

Routine Notice Healthcare
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USPTO Patent Grant: Antibody and CAR Binding to CD70 for Disease Treatment

The USPTO has granted patent US12583931B2 to Nanjing IASO Biotechnology Co., Ltd. for an antibody and chimeric antigen receptor (CAR) that specifically binds to CD70, intended for treating diseases related to CD70 expression. The patent covers the composition of the CAR and its application in disease treatment.

Routine Rule Pharmaceuticals
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USPTO Patent Grant: Bispecific Antibodies Targeting CD47 and PD-L1

The USPTO has granted patent US12583922B2 for bispecific antibodies targeting CD47 and PD-L1. The patent, assigned to Novimmune SA, covers methods of making and using these antibodies for treating cancers associated with malignant cells expressing CD47 and/or PD-L1.

Routine Notice Pharmaceuticals
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Patent Grant: IGFR-like Receptor Antagonists for Diabetes Treatment

The USPTO has granted a patent (US12583928B2) for novel Insulin-like Growth Factor 1 Receptor (IGFR)-like receptor antagonists and agonists. These compounds are intended for the treatment of diabetes.

Routine Notice Pharmaceuticals
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Olympus HF Cable Recall

Health Canada has issued a Type II recall for the Olympus HF Cable (Model WA00014A) due to performance issues leading to insulation wear, corrosion, and failure. The recall follows 109 complaints, including 17 reports of minor burns, though no serious injuries were reported.

Urgent Enforcement Medical Devices
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iVascular Navitian Recall

Health Canada has issued a Type II recall for the iVascular Navitian medical device due to a potential risk of material fragment loss from outer layer deterioration. The recall affects specific lot and serial numbers and is being managed by the manufacturer, Life Vascular Devices Biotech S.L.

Priority review Enforcement Medical Devices
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USPTO Patent Grant: Lignin Solvation for Antimicrobial Therapeutics

The USPTO has granted a patent (US12582670B2) to the University of Florida Research Foundation, Inc. for a method of solvating lignin in aqueous buffers for use in antimicrobial therapeutics. The patent covers aqueous lignin solutions and their applications in treating microbial infections and forming antimicrobial products.

Routine Rule Pharmaceuticals
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USPTO Patent US12582667B2 for Gastrointestinal Cancer Treatment

The USPTO has granted patent US12582667B2 to The Rockefeller University for compounds and methods to treat metastatic gastrointestinal cancer. The patent details a method involving suppressing the enzymatic activity of DHODH and/or decreasing creatine levels via suppression of the creatine transporter SLC6a8.

Routine Notice Pharmaceuticals
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USPTO Patent Grant for Low Dose Therapeutic Treatment

The USPTO has granted patent US12582666B2 to Syqe Medical Ltd. for a low dose therapeutic treatment system. The patent covers a system for delivering predetermined amounts of THC, with specific limits on dosage and delivery time, utilizing a decision module and an inhaler device.

Routine Notice Pharmaceuticals
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USPTO Patent Grant for Injectable Pharmaceutical Compositions by Zoetis

The USPTO has granted patent US12582662B2 to Zoetis Services LLC for injectable pharmaceutical compositions. The patent covers formulations including a cyclodextrin, a hydrophobic drug, a co-solvent, and a preservative, designed for effective preservation according to pharmacopoeia standards.

Routine Notice Pharmaceuticals
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USPTO Grants Patent for RSV Inhibitors

The USPTO has granted a new patent (US12582661B2) to SHANGHAI ARK BIOPHARMACEUTICAL CO., LTD. for a class of respiratory syncytial virus (RSV) inhibitors. The patent, effective March 24, 2026, covers compounds with potential advantages in activity and in vivo exposure compared to existing treatments.

Routine Notice Pharmaceuticals
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USPTO Patent Grant: Methods Treating Disorders Using CSFIR Inhibitors

The USPTO has granted patent US12582655B2 to Deciphera Pharmaceuticals, LLC for methods of treating cancers and other tumors using CSFIR inhibitors. The patent covers methods related to the proliferation, depletion, or repolarization of tumor-associated macrophages (TAMs).

Routine Notice Pharmaceuticals
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USPTO Grants Patent for Sulfur Compound in Tumor Treatment

The USPTO has granted patent US12582641B2 to SHANGHAITECH UNIVERSITY for a sulfur-containing compound based on a glutarimide skeleton and its application in treating tumors. The patent filing date was February 25, 2020, and the grant date is March 24, 2026.

Routine Notice Pharmaceuticals
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USPTO Patent Grant: Dapansutrile for Breast Cancer Treatment

The USPTO has granted patent US12582628B2 to Olatec Therapeutics, Inc. for a method of treating breast cancer using dapansutrile, optionally in combination with a checkpoint inhibitor. The patent covers methods of treatment and has an effective date of March 24, 2026.

Routine Notice Pharmaceuticals
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USPTO Grants Patent for Glutathione Trisulfide in Neuroprotection

The USPTO has granted a patent (US12582693B2) to The General Hospital Corporation for methods using glutathione trisulfide (GSSSG) in neuroprotection. The patent covers uses in treating neurodegenerative diseases and reducing ischemic injury risk.

Routine Rule Pharmaceuticals
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Donepezil Topical Formulation Patent for Intradermal Use

The USPTO has granted a patent (US12582637B2) to Arctic Therapeutics HF for a topical formulation of donepezil intended for intradermal application. The patent covers compositions and methods of use for this specific formulation.

Routine Notice Pharmaceuticals
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USPTO Patent Grant: Immunopotentiating Amino Acid Mineral Complex

The USPTO has granted a patent (US12583873B2) to BTN CO., LTD. for an amino acid mineral complex with immunopotentiating activity. This complex can be used in compositions for foods, pharmaceuticals, or feeds to enhance immunity or antibody production in humans and animals.

Routine Notice Pharmaceuticals
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USPTO Grants Patent for Idiopathic Pulmonary Fibrosis Treatment

The USPTO has granted a patent (US12582653B2) to BEIJING TIDE PHARMACEUTICAL CO., LTD. for a compound and method to treat idiopathic pulmonary fibrosis. The patent covers compounds represented by formula (I) and their pharmaceutically acceptable derivatives.

Routine Notice Pharmaceuticals
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USPTO Patent Grant for GIP Receptor Antibodies

The USPTO has granted patent US12583930B2 to Crystal Bioscience Inc. for GIP receptor antibodies designed to treat metabolic disorders, specifically those related to glucose metabolism. The patent covers antibodies that bind to and inhibit the human glucose-dependent insulinotropic polypeptide (GIP) receptor.

Routine Notice Pharmaceuticals
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USPTO Grants Patent for Benzothiazole Compound for Parkinson's and Restless Leg Syndrome

The USPTO has granted a patent (US12583829B2) to Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. for a salt of a benzothiazole compound and its crystal form. The patent covers the use of this compound in the preparation of drugs for treating Parkinson's disease and restless leg syndrome.

Routine Notice Pharmaceuticals

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