Industry News
The latest medical device regulatory news, clinical trials, and market insights
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FDA Draft Guidance Advances Use of Bayesian Methods in Clinical Trials
The U.S. Food and Drug Administration (FDA) has issued new draft guidance aimed at streamlining clinical trials through the application…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…
FDA Strengthens Recall Processes After Infant Botulism Cases Linked to ByHeart Formula
The U.S. Food and Drug Administration (FDA) has announced plans to enhance the effectiveness of food recalls. This comes after…
FDA Seeks Venture Capital Input to Reform Contracting for Public Health Innovation
The U.S. Food and Drug Administration (FDA) is exploring new avenues for collaboration with America’s top innovators to advance public…
FDA Recognizes Two Investigational Products with National Priority Vouchers for Affordability Breakthroughs
On January 12, 2026, the U.S. Food and Drug Administration (FDA) announced a significant milestone in regulatory advancements by awarding…