A Phase 3 multicenter, open-label, randomized study with single-arm extension period has been completed, assessing pharmacokinetics, safety, and efficacy of macitentan versus standard of care in children with pulmonary arterial hypertension. The trial evaluated the investigational therapy in the pediatric population with this rare cardiovascular condition.

11h ago·1 min read

FDA & Healthcare

Kluster Fun Tabletop Magnet Chess Games

Product Recall

FDA & Healthcare

Product Recall: Kluster Fun Tabletop Magnet Chess Games

Kluster Fun Tabletop Magnet Chess Games were recalled due to presence of loose magnet sets that violate the federal magnet set regulation. The products contain high-powered magnets that pose an ingestion hazard, violating 16 CFR part 1262.

Kluster Fun Tabletop Magnet Chess Games·11h ago·1 min read

FDA & Healthcare

ProRider Bicycle Helmets

Product Recall

FDA & Healthcare

Product Recall: ProRider Bicycle Helmets

ProRider Bicycle Helmets were recalled for failure to comply with the federal safety standard for bicycle helmets. The helmets do not meet the requirements of CPSC's bicycle helmet regulation at 16 CFR part 1203.

ProRider Bicycle Helmets·11h ago·1 min read

FDA & Healthcare

LIVEHOM 11-Drawer Dressers

Product Recall

FDA & Healthcare

Product Recall: LIVEHOM 11-Drawer Dressers

LIVEHOM 11-Drawer Dressers were recalled for tip-over hazard and noncompliance with the federal mandatory stability standard for clothing storage units. The products do not meet the ASTM F2057-23 furniture stability requirements.

LIVEHOM 11-Drawer Dressers·11h ago·1 min read

FDA & Healthcare

17 Stories Furniture 14-Drawer Dressers

Product Recall

FDA & Healthcare

Product Recall: 17 Stories Furniture 14-Drawer Dressers

17 Stories Furniture 14-Drawer Dressers were recalled due to tip-over hazard and violation of the federal mandatory stability standard for clothing storage units. The dressers fail to meet ASTM F2057-23 requirements for furniture stability.

17 Stories Furniture 14-Drawer Dressers·11h ago·1 min read

FDA & Healthcare

Tomum Hair Regrowth Treatment with Minoxidil for Men and Women Spray Bottles

Product Recall

FDA & Healthcare

Product Recall: Tomum Hair Regrowth Treatment with Minoxidil for Men and Women Spray Bottles

Tomum Hair Regrowth Treatment with Minoxidil spray bottles were recalled for failing to meet child-resistant packaging requirements. The products violated the Poison Prevention Packaging Act by lacking adequate child-resistant closures.

Tomum Hair Regrowth Treatment with Minoxidil for Men and Women Spray Bottles·11h ago·1 min read

FDA & Healthcare

Cubimana Island Storm 3 In 1 Building Sets with LED Lights

Product Recall

FDA & Healthcare

Product Recall: Cubimana Island Storm 3 In 1 Building Sets with LED Lights

Cubimana Island Storm 3 In 1 Building Sets with LED Lights were recalled due to presence of button or coin batteries that are accessible without a tool. The batteries pose an ingestion hazard to young children, violating federal battery accessibility regulations.

Cubimana Island Storm 3 In 1 Building Sets with LED Lights·11h ago·1 min read

FDA & Healthcare

Forever 21 Kids Disney Mickey Mouse Pajama Pants

Product Recall

FDA & Healthcare

Product Recall: Forever 21 Kids Disney Mickey Mouse Pajama Pants

Forever 21 Kids Disney Mickey Mouse Pajama Pants were recalled due to violation of federal flammability standards for children's sleepwear. The garments failed to meet the flame resistance requirements under the flammable fabrics regulations.

Forever 21 Kids Disney Mickey Mouse Pajama Pants·11h ago·1 min read

FDA & Healthcare

TheKiddoSpace Peg Dolls in Cups Toys

Product Recall

FDA & Healthcare