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...
pain remains especially urgent. The company has initiated an additional pivotal U.S. Phase 3 trial to support a future FDA submission. Based on the current development plan, the company anticipates a first data read-out in 2027 and, subject to...
TelyRx Holdings Inc. a technology-enabled healthcare and online pharmacy platform focused on expanding access to FDA-approved medications across the United States, today announced it has surpassed one million prescriptions filled nationwide since...
the single-use neuro-endoscope, has officially received certification from the Taiwan Food and Drug Administration (TFDA), marking an important milestone in the company's development in medical imaging and endoscopic applications. Following its...
Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has approved XOCOVA® (ensitrelvir), an oral antiviral, for post-exposure prophylaxis (PEP) of COVID‑19 in adults and...
new EC approval reinforces the expanding impact of Opdivo in cHL, building upon the U.S. Food and Drug Administration (FDA) approval of Opdivo in combination with AVD for previously untreated Stage III or IV cHL in adults and pediatric patients 12...
precision medicine company, announced that it has received approvals from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx and FoundationOne®Liquid CDx to be used as companion diagnostics for Pfizer’s TALZENNA® (talazoparib) in...
Mr. Pitts is a globally recognized expert in healthcare policy, regulatory science, and U.S. Food and Drug Administration (FDA) governance. He previously served as Associate Commissioner at the FDA and as a member of the U.S. Senior Executive...
