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Reata Pharmaceuticals Announces Approval of Prior Approval Supplement for SKYCLARYS® (Omaveloxolone) and Commercial Availability of SKYCLARYS for Patients with Friedreich’s Ataxia

Reata Pharmaceuticals, Inc. announced that the United States Food and Drug Administration has approved the Prior Approval Supplement to update the drug substance specification for SKYCLARYS®, the first and only FDA approved drug for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.

Reata Pharmaceuticals Announces Approval of Prior Approval Supplement for SKYCLARYS® (Omaveloxolone) and Commercial Availability of SKYCLARYS for Patients with Friedreich’s Ataxia Read More »

Xuanzhu Biopharm, a subsidiary of Sihuan Pharmaceutical, Its Innovative Drug Anaprozole Sodium Enteric-coated Tablets Obtains Drug Registration Approval From NMPA

Sihuan Pharmaceutical Holdings Group Ltd. together with its subsidiaries, is pleased to announce that Xuanzhu Biopharmaceutical Co., Ltd., a non-wholly owned subsidiary of Company, has received a drug registration approval from the National Medical Products Administration of China of Anaprozole Sodium Enteric-coated Tablet for the treatment of duodenal ulcer.

Xuanzhu Biopharm, a subsidiary of Sihuan Pharmaceutical, Its Innovative Drug Anaprozole Sodium Enteric-coated Tablets Obtains Drug Registration Approval From NMPA Read More »

Kalos Medical Receives Korean MFDS Innovative Medical Device Designation for DENEX Hypertension Treatment System

Kalos Medical Inc. announced on June 23rd that South Korea’s Ministry of Food and Drug Safety designated the company’s DENEX hypertension treatment system as an Innovative Medical Device, a designation that recognizes medical devices that significantly improve safety and efficacy compared to existing medical devices and treatments.

Kalos Medical Receives Korean MFDS Innovative Medical Device Designation for DENEX Hypertension Treatment System Read More »

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