and 300mg Alpha-Lipoic Acid (≥99% purity). The formulation is delivered in vegetarian HPMC capsules, manufactured in FDA-registered, cGMP-certified facilities with third-party testing for purity, potency, and safety. About Triquetra Health...
integrated human plasma platform spanning plasma collection, manufacturing, and commercialization. Through its network of FDA- and EMA-licensed plasma collection centers in New Jersey and Pennsylvania, the Company supplies human plasma to leading...
Roche announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its cobas® BV/CV (Bacterial vaginosis/Candida vaginitis) assay. This molecular diagnostic test provides results for both Bacterial vaginosis (BV) and...
with independent intellectual property rights, received marketing approval from the U.S. Food and Drug Administration (FDA) in late May of this year. It is the first China-originated intravenous anesthetic new drug to enter the global market,...
with Merck, and Ono Pharmaceutical. The combination of cetuximab, encorafenib and FOLFOX received accelerated FDA approval in December 2024 for treatment-naïve patients based on ORR data, and full FDA approval in February 2026 based on PFS and OS...
BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) for full approval in children with achondroplasia. . "This...
On July 2, 2026, the U.S. Food and Drug Administration (FDA) approved the use of wilate® (von Willebrand Factor/Coagulation Factor VIII Complex [Human]) for routine prophylaxis to reduce the frequency of bleeding episodes in pediatric patients...
Starting today FDA-approved Wegovy® (semaglutide) is available through the Medicare GLP-1 Bridge, a new access pathway for millions of older adults living with obesity. Obesity is a serious, common chronic disease among older Americans and Wegovy®...
Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP standards. About Avenacy Avenacy is a U.S.-based specialty pharmaceutical company focused on...
Ionis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved TRYNGOLZA® (olezarsen) as an adjunct to diet to reduce triglycerides (TG) and the risk of acute pancreatitis in adults with severe...
Ionis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved TRYNGOLZA® (olezarsen) as an adjunct to diet to reduce triglycerides (TG) and the risk of acute pancreatitis in adults with severe...
ZETA SURGICAL and HOPE Therapeutics, an NRx Pharmaceuticals company announced the first patient treatment with the FDA-cleared Zeta TMS Navigation System at a HOPE Therapeutics clinic in Sarasota. HOPE has installed Zeta TMS Navigation Systems at...
also visit www.upsher-smith.com or call 1-888-650-3789. You are encouraged to report suspected adverse reactions to the FDA by visiting www.fda.gov/medwatch or by calling 1-800-FDA-1088. About Duchenne Muscular Dystrophy Duchenne muscular dystrophy...
Merck known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) to include children and...
Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP standards. U.S. sales of Bortezomib for Injection were approximately $43 million for the twelve...
surgeries. The WCS® holds CE mark under MDR — the first cortical strip for IONM to achieve this certification — as well as FDA clearance and is commercially available in Europe, USA, and Australia. Strengthening WISE's Governance The round's...
as more health insights become available. Phase three will introduce additional physician-prescribed peptides, pending the FDA’s advisory committee ruling on peptide reclassification in July. ABOUT RUGIET Since 2020, Rugiet has combined clinical...
Bayer announced that the U.S. Food and Drug Administration (FDA) approved AMBELVIST® (gadoquatrane), a new, intravenous macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) indicated for contrast-enhanced magnetic resonance imaging (MRI) to...
and clinical development of its groundbreaking technologies. In 2022, the U.S. Food and Drug Administration (FDA) granted Breakthrough Device status to XT-ViVo® and TimeSeal® for human kidney preservation up to 120 hours for transplant. For more...
with wAIHA, a rare, life-threatening condition for which patients currently have no U.S. Food and Drug Administration (FDA)-approved treatment options. "These data from the Phase 2/3 ENERGY study showed the rapid onset of effect and durable...
