Regulatory Affairs

January 15, 2026 Dr. Hatem Rabeh

FDA Warns of Dislodged Deaeration Chambers in Vantive Prismaflex Dialysis Tubing Sets

The FDA has issued an early alert regarding a critical issue with certain Vantive Prismaflex dialysis tubing sets. Clinical, quality,…

January 15, 2026 Dr. Hatem Rabeh

Swissmedic Approves Redundancy Plan for Headcount Reduction

Swissmedic has finalized a redundancy scheme in response to an announced staff reduction at the organization. The plan has been…

January 15, 2026 Dr. Hatem Rabeh

Swissmedic Expands Approval for Calquence® Therapeutic Indication

On January 15, 2026, Swissmedic officially approved an extension of the therapeutic indication for Calquence®, marking a significant regulatory development…

Temporary Authorization for Abilify i.m. Injection Solution Due to Supply Shortage

Swissmedic, Switzerland’s authority for therapeutic products, has announced the temporary authorization for the distribution of Abilify i.m. injection solution (7.5mg/ml)…

Swissmedic Confirms New Blood Donation Guidelines to Address vCJD Concerns

On February 1, 2026, new blood donation criteria from Swiss Transfusion SRC will take effect, marking a critical update in…

Spring & Mulberry Recalls Mint Leaf Date Sweetened Chocolate Bars Over Salmonella Concerns

Spring & Mulberry Issues Recall of Mint Leaf Chocolate Bars Over Potential Salmonella Contamination On January 12, 2026, Spring &…

FDA Draft Guidance Advances Use of Bayesian Methods in Clinical Trials

The U.S. Food and Drug Administration (FDA) has issued new draft guidance aimed at streamlining clinical trials through the application…

FDA Authorizes First Pediatric Treatment for Rare Menkes Disease

The U.S. Food and Drug Administration (FDA) has approved Zycubo (copper histidinate) injection, marking a significant regulatory milestone as the…

Swissmedic welcomes Vincenza Trivigno as new Executive Director

On January 12, 2026, Swissmedic, the Swiss agency responsible for the authorization and monitoring of therapeutic products, announced a significant…

Streamline Medical Device Registration with Swissmedic: Free Webinar Highlights swissdamed Tools

Swissmedic, Switzerland’s national agency for therapeutic products, is offering a complimentary webinar on May 28, 2026. This online session will…

FDA Grants National Priority Voucher to New Treatment for Multiple Myeloma Following Phase 3 Success

The U.S. Food and Drug Administration (FDA) has awarded a national priority voucher for teclistamab in combination with daratumumab. This…

FDA Removes Key Restriction on Real-World Evidence in Drug and Device Applications

The U.S. Food and Drug Administration (FDA) announced a significant regulatory update on January 12, 2026, aimed at expanding the…