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Takeda yanks FDA filing for dengue vaccine, citing data disagreement with regulator

Fierce Pharma

travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting. | U.S. travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting.

FDA 199
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US FDA approves Blueprint Medicines’ indolent systemic mastocytosis therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. The precision therapy has been designed for potently and selectively inhibiting KIT D816V, which is the main underlying driver of the disease.

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FDA drops PreCert report, new digital health guidances

pharmaphorum

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

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FDA clears way for retail pharmacy sale of abortion pills

pharmaphorum

Retail pharmacies in the US will be able to dispense mifepristone-based therapies to end pregnancies after the FDA introduced changes to its regulatory framework for the products. The American College of Obstetricians and Gynaecologists (ACOG) said the FDA’s decision was a victory for women’s health.

Retail 83
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Axial3D Receives FDA Clearance for Axial3D INSIGHT™ Medical Image Segmentation Platform

Legacy MEDSearch

Axial3D, a leader in medical segmentation and 3D solutions, today announced that it is the first to receive FDA clearance for an automated, AI-driven, cloud-based segmentation platform for orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications. Are you hiring?

Medical 52
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FDA warns of hidden drug ingredients in Dr Ergin’s SugarMD

Pharmaceutical Technology

Patients who have used the products should consult their healthcare provider and properly discard the product.

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First-in-class biologic approved for rare lung disease

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved WINREVAIR ( sotatercept -csrk) for subcutaneous injection (45mg, 60mg) for adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1). Further findings from the Phase III trial The FDA approval is based on results from the Phase III STELLAR trial.