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Gilead wins patent battle with US government over HIV PrEP drugs

Pharmaceutical Technology

The FDA approved Truvada as the first PrEP treatment in July 2012, with Descovy receiving a nod for this use in October 2019. While both Descovy and Truvada contain emtricitabine, they feature different forms of the antiviral tenofovir. Truvada contains tenofovir disoproxil fumarate, whereas Descovy uses tenofovir alafenamide.

Drugs 264
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Konvomep Gets FDA Approval as a New Oral Liquid Formulation Option of Omeprazole

XTalks

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). Patients are our priority, and our purpose is to bring them new formulations that help them benefit from established medicines.

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Full FDA approval for endometrial cancer treatment

Drug Discovery World

The US Food and Drug Administration (FDA) has granted full approval for Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a US FDA-approved test. complete response rate and a 29.8% partial response rate.

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FDA Approves First Fecal Microbiota Product

The Pharma Data

FDA Approves First Fecal Microbiota Product. Food and Drug Administration approved Rebyota, the first fecal microbiota product approved by the agency. Rebyota is approved for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older. Today, the U.S.

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US FDA approves Takeda’s HyQvia to treat PI in children

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Takeda ’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years. It was previously approved in the US to treat PI in adults.

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Avillion, AstraZeneca asthma rescue treatment given FDA approval

pharmaphorum

Airsupra (PT027), a new asthma rescue treatment developed by AstraZeneca (AZ) and development partner Avillion, has been approved by the US Food and Drug Administration (FDA). Additionally, under its 2018 agreement, Avillion had regulatory responsibility, including filing the New Drug Application (NDA) through to FDA approval.

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FDA greenlights new long-term treatment option for opioid use disorder

Pharmaceutical Technology

Braeburn submitted data from a 24-week Phase III trial (NCT02651584) to support approval. The FDA approval adds a further treatment avenue to tackle the opioid crisis in the US. The year 2023 has seen some landmark regulatory developments to contain the crisis.