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 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 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 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 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.

FDA Issues Emergency Use Authorization for F10 Antiseptic Wound Spray for New World Screwworm

The FDA has issued an Emergency Use Authorization (EUA) for F10 Antiseptic Wound Spray with Insecticide for the prevention and treatment of New World screwworm in multiple animal species, excluding domestic dogs and cats. This authorization allows for broader use than previously approved products, with specific food safety guidelines for treated animals.

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 Guidance on Defining Drug Use Durations for Medically Important Antimicrobials

The FDA has finalized guidance (GFI #273) recommending how animal drug sponsors can voluntarily establish defined durations of use for medically important antimicrobial drugs administered in feed to food-producing animals. Over 100 drugs are affected, and sponsors are expected to submit revised labeling within approximately three years.

FDA Approves First Generic Florfenicol and Flunixin Injection

The FDA has approved nixiFLOR, the first generic version of florfenicol and flunixin meglumine injection for treating bovine respiratory disease. This approval marks a new generic option for beef and non-lactating dairy cattle, with a withdrawal period of 38 days.

FDA Notification: Influenza Vaccine Safety Labeling Change

The FDA has notified ID Biomedical Corporation of Quebec (GlaxoSmithKline Biologicals) of a required safety labeling change for its FLULAVAL influenza vaccine. Postmarketing studies indicate an increased risk of febrile seizures in young children following vaccination, necessitating updates to the product's prescribing information.

FDA Safety Labeling Change for FluMist

The FDA has notified MedImmune, LLC of a required safety labeling change for FluMist, an influenza vaccine. The change is based on postmarketing studies indicating an increased risk of febrile seizures in children aged 6 months through 4 years following vaccination.

FDA Safety Labeling Change for Fluzone Vaccine

The FDA has notified Sanofi Pasteur Inc. of a required safety labeling change for Fluzone vaccine. Postmarketing studies indicate an increased risk of febrile seizures in children aged 6 months through 4 years following vaccination. This change mandates updating the 'Warnings and Precautions' section of the vaccine's labeling.

FDA Notification: Safety Labeling Change for Influenza Vaccine

The FDA has notified GlaxoSmithKline Biologicals of a required safety labeling change for its FLUARIX influenza vaccine. Postmarketing studies indicate an increased risk of febrile seizures in children aged 6 months through 4 years following vaccination.

FDA Warns of Serious Risks from Unapproved Cell/Tissue Products

The FDA is warning consumers and healthcare professionals about the serious risks associated with unapproved human cell and tissue products, including patient deaths. The agency is investigating products like Laennec and reminds the public to report adverse events.

FDA CDRH Statements on Medical Device News and Regulatory Updates

The FDA's Center for Devices and Radiological Health (CDRH) provides a collection of statements and updates on medical device news and regulatory matters. This page serves as a repository for announcements, initiatives, and reports from CDRH, offering insights into their ongoing work and priorities.

FDA Approves First Device for Pancreatic Cancer

The FDA has approved the first medical device specifically designed to treat pancreatic cancer. This approval marks a significant advancement in the treatment options available for patients diagnosed with this disease.

FDA Lists Expiration Dates for At-Home COVID-19 Tests

The FDA has updated its list of authorized at-home COVID-19 diagnostic tests, including information on extended expiration dates. This guidance helps consumers and healthcare providers identify currently valid tests.

FDA Pilot for Medical Device Recall Communication

The FDA's Center for Devices and Radiological Health (CDRH) is launching a pilot program to improve the speed of communication regarding high-risk medical device recalls. This initiative focuses initially on specific device categories and aims to reduce the time between the FDA's awareness of a potential issue and public notification.

FDA Idea Lab for Home Health Medical Devices

The FDA has launched an Idea Lab as part of its Home as a Health Care Hub initiative to foster the development of new home health medical devices. The lab focuses on diabetes management as a test case, aiming to integrate devices for prevention, diagnosis, treatment, rehabilitation, and monitoring into patients' lifestyles.

FDA Guidance: Cancer Trial Eligibility Criteria - Laboratory Values

The FDA has issued new guidance on cancer clinical trial eligibility criteria, specifically focusing on laboratory values. The guidance aims to help sponsors and institutional review boards select appropriate laboratory values to avoid unjustified exclusions of diverse patient populations.

FDA Guidance: Inclusive Cancer Trial Eligibility Criteria

The FDA has issued new guidance recommending that sponsors and institutional review boards expand eligibility criteria for cancer clinical trials to include a wider range of patients, particularly concerning performance status. This aims to improve the diversity of clinical trial populations and ensure broader applicability of cancer treatments.

FDA Final Guidance on Bioresearch Monitoring Inspections

The FDA has issued final guidance detailing processes and practices for Bioresearch Monitoring inspections, as mandated by the Food and Drug Omnibus Reform Act of 2022. This guidance outlines record and information requirements, communication best practices, and inspection conduct for regulated entities.

FDA Guidance: Cancer Trial Eligibility Criteria

The FDA has issued new guidance regarding eligibility criteria for cancer clinical trials, specifically addressing washout periods and concomitant medications. This guidance aims to help sponsors and IRBs develop trials that are inclusive while ensuring participant safety. Comments on the guidance can be submitted at any time.

FDA Identifies Infusion Pump Software Correction as Most Serious Recall

The FDA has identified a software correction for the Fresenius Kabi Ivenix Large Volume Pump as its most serious type of recall, indicating a potential risk of serious injury or death. Affected healthcare providers are urged to update the pump software to version 5.10.2 as soon as possible and implement temporary risk mitigation measures.

Medline Industries Recalls Electrophysiology and Ultrasound Catheters

Medline Industries is expanding a recall of reprocessed electrophysiology and ultrasound catheters due to potential residual particulates. The FDA has classified this as the most serious type of recall, as the devices could cause serious injury or death. Affected customers are instructed to return or destroy the product.

Navafresh Recalls Rheumacare Capsules Due to Elevated Lead Levels

Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Rheumacare Capsules due to elevated lead levels found by the FDA. The recall impacts consumers nationwide and is being conducted with the FDA's knowledge.

Modern Warrior Recalls Dietary Supplement Due to Undeclared Ingredients

Modern Warrior is voluntarily recalling its 'Modern Warrior Ready' dietary supplement due to the presence of undeclared tianeptine, 1,4-DMAA, and aniracetam. The FDA is highlighting the serious health risks associated with these ingredients, including potential life-threatening cardiovascular events and suicidal ideation.

Gold Star Distribution Recalls FDA Products Due to Contamination

Gold Star Distribution, Inc. is recalling all FDA-regulated products held at its facility due to rodent, avian, and insect contamination and insanitary conditions. The FDA determined the facility operated under insanitary conditions, posing a significant risk of product contamination and potential illness from microorganisms like Salmonella.

FDA Recall of Silintan Capsules for Undeclared Meloxicam

Anthony Trinh, 123Herbals LLC is voluntarily recalling all lots of Silintan capsules due to the presence of undeclared meloxicam, an approved NSAID. The FDA analysis found the product to be an unapproved new drug, posing risks of serious health events.

Green Lumber Recalls Dietary Supplements for Undeclared Tadalafil

Green Lumber Holding, LLC is updating a recall for counterfeit dietary supplements falsely marketed as Green Lumber. The counterfeit products contain undeclared Tadalafil, a prescription drug, posing potential health risks. Consumers are advised to check lot numbers and discontinue use of affected products.

Financial Services Platform Test Approved by OSC, AMF, CIRO

Canada's OSC, AMF, and CIRO have approved Project Samara, an experimental research project evaluating a distributed ledger technology platform for bond transactions. The project involves major financial institutions and aims to assess the benefits of tokenized bond issuance and trading.

Canadian Securities Administrators Warn of Phishing Emails

The Canadian Securities Administrators (CSA) has issued a warning to registrants regarding phishing emails impersonating the CSA. These emails are suspected to be malicious attempts to obtain personal or confidential business information. Registrants are urged to be vigilant, verify sender authenticity, and report suspicious emails.

Canadian Securities Regulators Disrupt Over 7,500 Fraudulent Investment Websites

The Canadian Securities Administrators (CSA) announced the disruption of over 7,500 fraudulent investment websites targeting Canadians. This initiative highlights the CSA's use of regulatory and enforcement tools to combat online investment fraud and protect investors.

Canadian Securities Regulators Amend Benchmark Assurance Report Requirements

Canadian securities regulators have adopted amendments to Multilateral Instrument 25-102 concerning designated benchmarks and benchmark administrators. These changes clarify assurance report requirements for independent public accountants, specifying the level of assurance, report type, and submission timing, and introduce a new requirement for certain designated benchmarks. The amendments are set to come into force on May 5, 2026.

CSA Publishes 2025 Systemic Risk Committee Annual Report on Capital Markets

The Canadian Securities Administrators (CSA) has published its 2025 Systemic Risk Committee Annual Report on Capital Markets. The report analyzes financial market trends, emerging risks, and vulnerabilities in Canadian markets, and outlines CSA efforts to mitigate these risks.

Junior mineral exploration company pays $30,000 to BCSC

Junior mineral exploration company pays $30,000 to BCSC

Director Fined $1 Million for Crypto Trading Platform Fraud

The BC Securities Commission (BCSC) announced that Michael Ongun Gokturk, director of three defunct crypto companies, has agreed to pay $1 million for fraud related to their trading platform. Gokturk is also permanently banned from participating in B.C.'s investment market.

Canadian Securities Regulators Disrupt Fraudulent Investment Websites

Canadian securities regulators announced the disruption of over 7,500 fraudulent investment websites and 13,000 URLs between June 2025 and February 2026. This initiative aims to protect Canadians from online investment scams and crypto fraud.

BCSC Panel Finds Breach of Cease Trade Order

The BC Securities Commission (BCSC) panel found that Green Hygienics Holdings Inc. and its former CEO, Ronald Wayne Loudoun, breached a cease trade order by distributing millions of dollars worth of shares and promissory notes. Submissions on sanctions are now required.

CIRO Guidance on Digital Asset Custody for Crypto-Asset Trading Platforms

The Canadian Investment Regulatory Organization (CIRO) has issued new guidance on digital asset custody for Crypto-Asset Trading Platforms (CTPs). The framework establishes clear expectations for Dealer Members operating CTPs, addressing technological, operational, and legal risks associated with digital assets. It enhances existing custody and segregation requirements to protect investors.

CIRO Annual Compliance Report 2026 for Dealers

The Canadian Investment Regulatory Organization (CIRO) has released its 2026 Annual Compliance Report. The report highlights emerging compliance challenges for dealers, including cybersecurity, crypto asset trading platforms, and the use of AI, and provides guidance on addressing these issues to enhance investor protection.

CIRO Seeks New Members for Investor Advisory Panel

The Canadian Investment Regulatory Organization (CIRO) is seeking applications for its Investor Advisory Panel (IAP). The panel advises CIRO on regulatory policy and initiatives. Applications are due by March 31, 2026.

Canada Approves Financial Services Platform Test Using Blockchain

Canadian securities regulators (OSC, AMF, CIRO) have approved an experimental financial services platform test, Project Samara, involving RBC, TD Securities, and the Bank of Canada. The project will evaluate the use of distributed ledger technology for bond issuance, trading, and settlement using digital Canadian dollars.

CIRO Guidance Expands Decision-Making Supports for OEO Dealers

The Canadian Investment Regulatory Organization (CIRO) has published new guidance allowing Order Execution Only (OEO) dealers to expand decision-making supports offered to clients. This aims to empower DIY investors with better educational resources and tools while maintaining investor protection.

Financial Ombudsman Service Sets Case Resolution Targets

The UK Financial Ombudsman Service has published its plans and budget for the 2026/27 financial year, setting a target to resolve 245,000 cases. The service is consulting on these ambitious targets, which include resolving over 80% of cases within six months.

Financial Ombudsman Service Warns Students About Financial Pitfalls

The UK's Financial Ombudsman Service has issued a warning to university students about common financial pitfalls as they return to education. The notice aims to raise awareness of potential financial issues and inform students about the services available to help resolve disputes with financial providers.

Financial Ombudsman Service Sees Lowest Complaint Levels in Two Years

The UK's Financial Ombudsman Service (FOS) reported a significant decrease in new cases, with complaint volumes returning to levels seen in 2023/24. The period between October and December 2025 saw 47,300 complaints, down from 68,400 in the same quarter the previous year. This reduction is attributed to factors including the FCA's complaint handling pause for motor finance cases.

Financial Ombudsman Service Warns of Investment and Employment Scams

The UK Financial Ombudsman Service has issued a warning regarding a rise in online investment and employment scams. In 2025, the service received over 31,300 fraud and scam complaints, with approximately 20,000 involving authorised payments to scammers.

Financial Ombudsman urges young drivers on car insurance

The UK's Financial Ombudsman Service has issued a notice urging young drivers to make informed decisions about car insurance. The service highlights common pitfalls and issues, including policy cancellations, administrative problems, and claim disputes, based on over 1,200 complaints received from drivers under 25 last year.

FSA Analytical Notes on Regional Banks and Talent

The Financial Services Agency (FSA) of Japan has published its "FSA Analytical Notes (2026.2)", focusing on the analysis of human resource support by regional banks and talent shortages in firms. An English version is expected to be released shortly.