Tag: Designation
Merck Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skippin

Merck Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skippin

- Investigational oral MET inhibitor has previously received SAKIGAKE 'fast-track' regulatory designation in Japan - MET exon 14 skipping alterations and MET amplifications ...

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Hainan Airlines Awarded the SKYTRAX 5-Star Airline Designation for the 9th Consecutive Year

Hainan Airlines Awarded the SKYTRAX 5-Star Airline Designation for the 9th Consecutive Year

PARIS, June 18, 2019 /PRNewswire/ -- On June 18, Paris local time, international air transport rating organization SKYTRAX announced the winners of the 2019 SKYTRAX World ...

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Merck Announces EMA Orphan Drug Designation for Bifunctional Immunotherapy M7824 in Biliary Tract Cancer

Merck Announces EMA Orphan Drug Designation for Bifunctional Immunotherapy M7824 in Biliary Tract Cancer

DARMSTADT, Germany, December 20, 2018 /PRNewswire/ -- The information contained is not intended for distribution in the USA, Canada or the UK    - European Medicine ...

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Merck Receives Fast-Track Designation for Tepotinib in Non-Small Cell Lung Cancer in Japan

Merck Receives Fast-Track Designation for Tepotinib in Non-Small Cell Lung Cancer in Japan

DARMSTADT, Germany, March 27, 2018 /PRNewswire/ -- Not intended for UK- or US-based media  - Japanese Ministry of Health, Labour and Welfare Grants SAKIGAKE ...

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Kazia Receives FDA Orphan Designation for GDC-0084

Kazia Receives FDA Orphan Designation for GDC-0084

SYDNEY, Feb. 23, 2018 /PRNewswire/ -- Kazia Therapeutics Limited , an Australian oncology-focused biotechnology company, is pleased to announce that the United States Food and ...

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FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA® in Advanced Renal Cell Carcinoma

FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA® in Advanced Renal Cell Carcinoma

DARMSTADT, Germany and NEW YORK, December 21, 2017 /PRNewswire/ -- - Second Breakthrough Therapy Designation for avelumab in hard-to-treat cancer  - Renal ...

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Sequoia Sciences Receives FDA Fast Track Designation for Vaccine for Urinary Tract Infections Caused by Multidrug-Resistant Bacteria

Sequoia Sciences Receives FDA Fast Track Designation for Vaccine for Urinary Tract Infections Caused by Multidrug-Resistant Bacteria

Non-Antibiotic Treatment Approach May Reduce the Development of Antibiotic Resistance and Promote Antibiotic Stewardship ST. LOUIS, July 26, 2017 /PRNewswire/ -- Sequoia ...

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