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BioWorld - Wednesday, December 17, 2025
Home » Topics » Regulatory

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FDA approves Vyleesi for hypoactive sexual desire disorder in premenopausal women

June 25, 2019

FDA greenlights Cochlear's Nucleus Profile Plus series with greater MRI access, expanded connectivity

June 24, 2019
By Meg Bryant
Cochlear Ltd., of Sydney, received U.S. FDA approval for its Nucleus Profile Plus cochlear implant and the Nucleus 7 sound processor's new built-in connectivity, enabling direct streaming with compatible Android smartphones. The implant will be commercially available in the U.S. later this month.
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Japan first to approve Breztri Aerosphere for COPD

June 19, 2019

FDA approves Keytruda for metastatic SCLC after platinum and other prior therapy

June 19, 2019

Vanflyta approved in Japan for the treatment of relapsed/refractory FLT3-ITD AML

June 19, 2019

Rozlytrek approved in Japan for NTRK fusion-positive, advanced recurrent solid tumors

June 18, 2019

Tree SLIT-tablet against allergic rhinitis approved in Europe

June 11, 2019

FDA approves first chemoimmunotherapy regimen for patients with DLBCL

June 11, 2019

FDA approves Emgality for episodic cluster headache

June 5, 2019

FDA approves Zerbaxa for hospital-acquired and ventilator-associated bacterial pneumonia

June 4, 2019
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