相关临床试验
11
0 进行中
药物批准
131
批准总数
监管机构
2
监管机构数
成立时间
N/A
已完成
5
45.5%
终止
4
36.4%
撤回
2
18.2%
- Centric Compounding LLC recalled six lots of compounded injectable vials nationwide after elevated endotoxin levels were found in the glutathione active pharmaceutical ingredient used to make them. - The recall, dated September 9, covers three lots of Glutathione 200 mg/mL, two lots of Myer's Cocktail and one lot of Tri-Immune Boost, all 30 mL multidose vials. - Centric Compounding has received nine adverse event reports including fever, chills, chest pain, nausea, vomiting, headache and malaise, and the FDA warns of sepsis-like symptoms and death.
- B. Braun Medical Inc. is voluntarily recalling three lots of 0.9% Sodium Chloride Injection USP, 100 mL, in 150 mL PAB containers due to particulate matter identified as zinc oxide. - Administration of the contaminated solution carries a reasonable probability of life-threatening consequences, including pulmonary emboli, vascular occlusions, phlebitis, and systemic immune activation. - The affected product was distributed nationwide to hospitals and healthcare facilities from February 27, 2026 to August 3, 2026, with no reports of serious injury or death to date. - The recall is being conducted with the knowledge of the U.S. Food and Drug Administration, with customers directed to return product to the place of purchase.
- B. Braun Medical Inc. announced the launch of Rocuronium Bromide Injection, the first and only FDA-approved room-temperature-stable prefilled syringe formulation. - The 50 mg/5 mL preservative-free injection eliminates refrigeration requirements and offers a 24-month shelf life for improved storage flexibility. - The room-temperature stability simplifies pharmacy handling, supports smoother distribution, and helps preserve limited refrigerated space for other medications. - This product launch strengthens B. Braun's portfolio of essential injectable medications while supporting clinicians in fast-paced clinical environments.
- B. Braun Medical Inc. launched piperacillin and tazobactam for injection in its DUPLEX Drug Delivery System, offering one of the most utilized injectable antibiotics in the U.S. in a ready-to-activate format. - The DUPLEX system reduces medication errors by 54% compared to traditional compounding methods and cuts overall process time by nearly four minutes per dose through its closed-system design. - The product is indicated for multiple serious infections including intra-abdominal infections, nosocomial pneumonia, and community-acquired pneumonia, available in three different strengths. - This launch follows B. Braun's recent Nurse Approved Certification and represents part of the company's broader strategy to expand its injectable drug portfolio in the U.S. market.
- B. Braun Medical has received FDA approval for Piperacillin and Tazobactam in their DUPLEX Drug Delivery System, offering a more efficient administration method for this widely used antibiotic combination. - The innovative two-compartment container reduces process time by nearly four minutes per dose and decreases medication error likelihood by 54% compared to traditional compounding methods. - This approval marks B. Braun's second DUPLEX Drug launch in 2025, with the company planning to expand its injectable drug portfolio in the coming years to address medications in high demand.
- B. Braun Medical Inc. has launched the first-ever Emergency Department Single-Shot Nerve Block Tray, featuring the Ultraplex® 360 Needle with advanced echogenic technology for enhanced ultrasound visibility. - The innovative tray is designed to enable emergency department clinicians to perform precise nerve blocks efficiently, offering a safer alternative to opioid-based pain management. - Clinical data shows the nerve block system improves patient satisfaction, reduces pain scores, and helps prevent the transition from acute to chronic pain while lowering hospital costs.
- B. Braun Medical's Introcan Safety 2 Deep Access IV Catheter has received FDA 510(k) clearance, expanding the Introcan Safety 2 portfolio. - The catheter combines features of the original Introcan Safety 2 Multi-Access and Deep Access catheters for enhanced vascular access. - Designed for deeper veins and longer dwell times, it aims to reduce PIVC restarts and the need for more invasive procedures. - The catheter includes passive safety needlestick protection and multi-access blood control to minimize blood exposure during IV therapy.
• The FDA granted traditional approval to Sirturo (bedaquiline) for treating rifampin- and isoniazid-resistant tuberculosis in adults and children, based on Phase 3 STREAM study data. • mResvia, an mRNA-based vaccine, received FDA approval for preventing lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 years and older. • Capvaxive, a pneumococcal 21-valent conjugate vaccine, was approved for preventing invasive disease and pneumonia caused by Streptococcus pneumoniae in adults 18 years and older. • Several critical care medical devices, including infusion pumps and chest compression devices, were recalled due to potential for serious adverse health consequences.
