Tag: FDA
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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Super Antioxidant Ergothioneine Achieves GRAS Status from FDA

Super Antioxidant Ergothioneine Achieves GRAS Status from FDA

Decision Drives Anti-Aging Market Emerging Studies Reveal Ergothioneine consumption is Correlated to Reducing Mild Cognitive Impairment RANCHO SANTA MARGARITA, California, ...

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FDA Premarket Approval Granted for DT MedTech's Hintermann Series H3(TM) Total Ankle Replacement System

FDA Premarket Approval Granted for DT MedTech's Hintermann Series H3(TM) Total Ankle Replacement System

BALTIMORE, June 5, 2019 /PRNewswire/ -- DT MedTech, LLC (DTM) announced today that the Hintermann Series H3(TM) (H3) Total Ankle Replacement (TAR) System has received ...

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Office of Generic Drugs (OGD/FDA) Awards $1M FDA Contract to CUBRC and EpiVax for Demonstration and Validation of Immunogenicity Risk Assessment

Office of Generic Drugs (OGD/FDA) Awards $1M FDA Contract to CUBRC and EpiVax for Demonstration and Validation of Immunogenicity Risk Assessment

PROVIDENCE, Rhode Island, Oct. 2, 2018 /PRNewswire/ -- EpiVax, Inc. ("EpiVax") and CUBRC, Inc. ("CUBRC") announced today that they have been awarded a two-year $1 million ...

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Kyowa Kirin Announces FDA Approval of Poteligeo® (mogamulizumab-kpkc) for the Treatment of Mycosis Fungoides and Sézary Syndrome

Kyowa Kirin Announces FDA Approval of Poteligeo® (mogamulizumab-kpkc) for the Treatment of Mycosis Fungoides and Sézary Syndrome

TOKYO, August 8, 2018 /PRNewswire/ -- - Poteligeo has been approved for the treatment of the two most common types of Cutaneous T-cell lymphoma (CTCL) in ...

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Norgine Announces US FDA Approval for PLENVU® (NER1006) – 1 Litre PEG Based Bowel Cleansing Preparation for Colonoscopy

Norgine Announces US FDA Approval for PLENVU® (NER1006) – 1 Litre PEG Based Bowel Cleansing Preparation for Colonoscopy

AMSTERDAM, May 7, 2018 /PRNewswire/ -- - US launch date: second half of 2018  - In Europe, PLENVU(R) is available through Norgine  Norgine B.V. today ...

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Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT® (macitentan) for the Treatment of Chronic Thromboemboli

Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT® (macitentan) for the Treatment of Chronic Thromboemboli

Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT® (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension ...

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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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OMNIlife science(TM), Inc.  Receives 510(k) Clearance from FDA for Revolutionary Robotic Tissue Balancing Device for OMNIBotics® Technology Platf

OMNIlife science(TM), Inc. Receives 510(k) Clearance from FDA for Revolutionary Robotic Tissue Balancing Device for OMNIBotics® Technology Platf

Breakthrough Technology Offers Orthopedic Surgeons the Ability to Combine Accuracy of Robotic-Assisted Bone Cutting and Actively Manage Soft Tissue RAYNHAM, Mass., Sept. 6, ...

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