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BioWorld - Saturday, February 28, 2026
Home » Topics » Regulatory

Regulatory
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Incyte wins FDA approval for first targeted cholangiocarcinoma treatment

April 21, 2020
By Michael Fitzhugh
With a coronavirus task force briefing unfolding at the White House late on April 17, an FDA eager to show its ongoing commitment to tackling other disease amid the pandemic, granted accelerated approval to Incyte Corp.'s Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma.
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Regulatory front for April 21, 2020

April 21, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory action for April 21, 2020

April 21, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainlab, Inspire Medical Systems, Labcorp, Roche.
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Regulatory actions for April 21, 2020

April 21, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alk-Abello, Bayer, Beigene, Boehringer Ingelheim, Hope, Myovant, Passage.
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Regulatory front for April 21, 2020

April 21, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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vent-multiplexor.png

Vent Multiplexor’s ventilator-sharing device wins FDA nod for emergency use

April 20, 2020
By Meg Bryant
The U.S. FDA has granted emergency use authorization (EUA) to New Haven, Conn., startup Vent Multiplexor LLC for its emergency rescue co-ventilation device. Developed in collaboration with Yale New Haven Hospital, the Vent Multiplexor enables individualized mechanical ventilation of two adults on a single ventilator – lessening demand for more critical care machines in the ongoing COVID-19 outbreak.
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Map of Europe

European Parliament throws its support behind one-year pause for MDR

April 20, 2020
By Nuala Moran
LONDON – The European Parliament gave its full backing to the emergency measure to delay the Medical Device Regulation (MDR), voting by 693 to 1 in favor of postponing implementation from May 26 this year, to May 26, 2021. The delay will “allow health authorities and manufacturers alike to prioritize the fight against the coronavirus pandemic” by keeping existing procedures in place, the parliament said in a statement.
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Ortho-vitros-antibody-blood-test.png

Ortho Clinical Diagnostics scores win with total antibody test for COVID-19

April 20, 2020
By Liz Hollis
The COVID-19 pandemic has moved rapidly over the past few weeks, and Ortho Clinical Diagnostics Inc. is doing its part to help during the crisis. To that end, the Raritan, N.J.-based company has worked to successfully secure an emergency use authorization (EUA) for its total antibody assay for COVID-19, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 total reagent pack and calibrators.
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Microscope image of SARS-CoV-2

Osang becomes first Korean company to win FDA emergency authorization

April 20, 2020
By Gina Lee
HONG KONG – South Korea’s Osang Healthcare Co. Ltd. became the first Korean company to receive the U.S. FDA’s emergency use authorization (EUA) for its COVID-19 test kit. In a letter dated April 18, 2020, the FDA informed Osang of its authorization for the company’s Genefinder COVID-19 Plus Realamp Kit.
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Regulatory actions for April 20, 2020

April 20, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytosorbents, Endospan, Fosun Pharma, Foundation Medicine, Genosensor, Osang Healthcare.
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