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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 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 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 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 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 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 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 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.

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.