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Regulatory
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Incyte wins FDA approval for first targeted cholangiocarcinoma treatment

April 20, 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 actions for April 20, 2020

April 20, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D, Futura, Genentech, Mustang, Precigen.
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FDA approves Tukysa for advanced, unresectable or metastatic HER2-positive breast cancer

April 20, 2020

Pemazyre approved in U.S. for advanced cholangiocarcinoma with FGFR2 fusions or rearrangements

April 20, 2020

Regulatory front for April 17, 2020

April 17, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: J1 Medical.
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Regulatory actions for April 17, 2020

April 17, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cirrusdx, Curative, Vent Multiplexor.
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Seattle Genetics wins FDA nod for Tukysa in breast cancer

April 17, 2020
By Randy Osborne
As expected – and well ahead of the Aug. 20 PDUFA date – Bothell, Wash-based Seattle Genetics Inc. (Seagen) won FDA clearance for the oral small-molecule breast cancer therapy tucatinib, a tyrosine kinase inhibitor branded Tukysa.
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Regulatory actions for April 17, 2020

April 17, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chi-Med, Everest, Redhill, Seattle Genetics.
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4-16-Synapse-Transaeris.png

Synapse gains EUA from FDA to stimulate the diaphragm of ventilated patients

April 16, 2020
By Stacy Lawrence
Case Western Reserve University spinout Synapse Biomedical Inc. has received emergency use authorization from the U.S. FDA for its Transaeris diaphragm pacing system (DPS) device to prevent and treat ventilator-induced diaphragm dysfunction (VIDD).
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Regulatory front for April 16, 2020

April 16, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Logan Labs.
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