Clue expands into digital contraception with FDA clearance

Clue expands into digital contraception with FDA clearance

Clue, a Berlin-based femtech company, announced today that it has received FDA clearance to launch Clue Birth Control, an all-digital form of contraceptive that relies on period tracking data. By combining user menstrual cycle data with Clue’s predictive algorithm, the

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FDA grants De Novo classification to Fifth Eye’s continuous hemodynamic status monitoring tool

The Analytic for Hemodynamic Instability tool can identify hemodynamic instability with 96% sensitivity and detects stable patients with 85% specificity.

Fifth Eye, a Michigan-based real-time clinical analytics company, announced today that the Food and Drug Administration has granted De Novo classification for its Analytic for Hemodynamic Instability (AHI) tool. The technology links with hospitals’ existing electrocardiograms to create a reading of

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FDA rejects Athenex’s oral chemotherapy, asks for another clinical trial

Breast cancer cells

Athenex’s lead drug candidate, an oral formulation of the chemotherapy paclitaxel, is intended to bring patients comparable, if not better, efficacy and fewer side effects than the intravenous version. But the company now faces questions about the drug’s safety in

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Breakthrough lupus drug ‘home grown’ by Edmonton doctor approved by FDA for use

Breakthrough lupus drug ‘home grown’ by Edmonton doctor approved by FDA for use

A breakthrough drug to treat lupus nephritis that was initially developed by an Edmonton biotech doctor in the 90s has now been approved for use by the FDA.Dr. Robert Foster said he thought up the initial idea for the

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FDA authorizes J&J’s 1-shot coronavirus vaccine

FDA authorizes J&J's 1-shot coronavirus vaccine

The Food and Drug Administration on Saturday gave emergency authorization to a coronavirus vaccine developed by Johnson & Johnson, making a third shot available at a critical moment for U.S. efforts to control COVID-19. J&J’s vaccine, which requires one dose

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FDA authorizes third Covid-19 vaccine, J&J pledges 20M shots by month’s end

FDA authorizes third Covid-19 vaccine, J&J pledges 20M shots by month’s end

The FDA has authorized Johnson & Johnson’s Covid-19 vaccine for emergency use, adding a third vaccination option—one that comes with storage and distribution advantages. The regulatory decision followed the review of an FDA advisory panel, which voted unanimously on Friday

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F.D.A. Expert Panel Endorses Johnson & Johnson’s Vaccine

F.D.A. Expert Panel Endorses Johnson & Johnson’s Vaccine

Johnson & Johnson’s Covid-19 vaccine was endorsed on Friday by a panel of experts advising the Food and Drug Administration, clearing the last hurdle before a formal authorization expected on Saturday, according to two people familiar with the agency’s plans.

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FDA approves Sarepta drug for muscular dystrophy with rare genetic mutation

Text FDA Approved appearing behind ripped brown paper.

  The FDA has approved a Sarepta Therapeutics drug for Duchenne muscular dystrophy, clearing the way for the company to commercialize its third therapy for the rare, muscle-wasting disease. Thursday’s decision covers patients with a particular genetic mutation that affects

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FDA advisers meet to review J&J’s one-shot coronavirus vaccine

FDA advisers back Pfizer, BioNTech vaccine, clearing way for emergency approval

A group of advisers to the Food and Drug Administration is meeting Friday to discuss whether the agency should clear Johnson & Johnson’s coronavirus vaccine for emergency use. Results from a large international study of roughly 40,000 volunteers found the

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FDA panel backs J&J’s coronavirus vaccine, clearing way for shot’s authorization

FDA panel backs J&J's coronavirus vaccine, clearing way for shot's authorization

A group of advisers to the Food and Drug Administration gave unanimous support for Johnson & Johnson’s single-shot coronavirus vaccine on Friday, setting up a decision from the agency on emergency authorization as soon as Saturday.  The committee, composed of

Read More FDA panel backs J&J’s coronavirus vaccine, clearing way for shot’s authorization