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Novaliq’s dry eye disease therapy receives US FDA approval

Pharmaceutical Technology

VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1%

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Top 30 New Medical Devices of 2024

XTalks

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Date of FDA approval : March 29, 2024 Approved for : To detect exposure to human parvovirus B19. TriClip size comparison photo. Photo courtesy of Abbott Medical.

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Gilead wins patent battle with US government over HIV PrEP drugs

Pharmaceutical Technology

This marks a significant development in a tumultuous dispute between the pharmaceutical company and the US government. This research dates to the mid-2000s when CDC scientists developed the PrEP regimen, argued the government. While both Descovy and Truvada contain emtricitabine, they feature different forms of the antiviral tenofovir.

Drugs 264
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In the News: October Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Still, navigating such patent issues during drug development can be difficult, and Camargo can assist in finding a safe course. Ken Phelps.

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In the News: September 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Discusses Focus Areas for PDUFA VII During Public Meeting. Continued development of the use of complex innovative trial designs.

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Konvomep Gets FDA Approval as a New Oral Liquid Formulation Option of Omeprazole

XTalks

Other factors like frequently consuming alcohol or using steroids often may also increase the chance of developing a gastric ulcer. On Friday, Azurity Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved their innovative oral liquid formulation Konvomep (omeprazole and sodium bicarbonate for oral suspension).

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In the News: October 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Guidance Addresses Real-World Evidence Data Standards. But what real-world evidence (RWE) would be accepted, and in what format?