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AGEPHA Pharma’s LODOCO gets US FDA approval for cardiovascular disease

Pharmaceutical Technology

Participants treated with LODOCO had a 31% reduction in the overall risk of cardiovascular death, spontaneous myocardial infarction or ischaemic stroke when added to statins and other cardiology prevention therapies, compared to those treated with placebo.

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Top 10 Heart and Vascular Medications Based on Recent Sales Data

XTalks

Their widespread adoption is driven by strong clinical evidence, broad FDA-approved indications and continued advancements in treatment protocols. Although the FDA approved generic versions from Micro Labs Limited and Mylan Pharmaceuticals Inc. Eliquis (Apixaban) Eliquis 2023 sales :$12.21

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Surmodics and Abbott’s Drug-Coated Balloon for Peripheral Artery Disease Gets FDA Approval

XTalks

Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics’ history,” said Gary Maharaj, president and CEO of Surmodics, in the company’s press release. “It SurVeil has an edge over IN.PACT as it is coated with a lower dose of the drug.

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BridgeBio’s Attruby (Acoramidis): A New, More Potent TTR Stabilizer for ATTR-CM

XTalks

BridgeBio’s leadership, including Neil Kumar, emphasizes the significance of Attruby’s approval as a cornerstone in their mission to develop therapies for genetic diseases. Looking ahead, the company plans to pursue regulatory approvals in Japan and Brazil, further expanding access to this life-changing treatment.

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Tryngolza (Olezarsen) Becomes First FDA-Approved Drug for Familial Chylomicronemia Syndrome

XTalks

For the first time in the US, adults living with familial chylomicronemia syndrome (FCS) have an FDA-approved treatment option. Investigational drug plozasiran , developed by Arrowhead Pharmaceuticals, is under review for FCS treatment. In clinical trials, it showed up to an 86 percent reduction in triglyceride levels.

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FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis

The Pharma Data

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.