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BioWorld - Monday, December 22, 2025
Home » Topics » Regulatory

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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

Conditional European marketing authorization for Zynteglo for transfusion-dependent beta-thalassemia

June 4, 2019

Jiangsu Hengrui Medicine's camrelizumab receives first approval in China for treatment of lymphoma

June 3, 2019

FDA gives nod to Theranica's wearable for the acute treatment of migraine pain

May 30, 2019
By Liz Hollis
Netanya, Israel-based Theranica Bioelectronics Ltd., which is focusing on the development of advanced electroceuticals for migraine and other pain disorders, scored a win at the U.S. FDA, with the agency granting its de novo request for the smartphone-controlled Nerivio Migra.
Read More

FDA approves sNDA for Vraylar for bipolar depression

May 28, 2019

FDA approves Piqray for HR+/HER2-, PIK3CA-mutated advanced breast cancer

May 27, 2019

Jakafi approved by FDA for steroid-refractory acute GvHD

May 27, 2019

FDA approves Zolgensma for spinal muscular atrophy

May 27, 2019
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