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BioMarin’s Biologics License Application for Valoctocogene Roxaparvovec Accepted for Priority Review by FDA with Review Action Date of August 21, 2020

No Advisory Committee Meeting Currently Planned to Review the ApplicationIf approved, 1st Gene Therapy in U.S. for the Treatment of Any Type of HemophiliaFDA Also Accepts Premarket Approval (PMA) Application for Companion Diagnostic Test, a 1st for a G… […]

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VistaGen Therapeutics Receives FDA Clearance of IND for Phase 2 Clinical Study of AV-101 as a Potential Treatment of Dyskinesia in Parkinson’s Disease Patients

Company also Receives a Notice of Allowance from the USPTO for a New AV-101 U.S. Patent for Treatment of Dyskinesia Induced by Levodopa Therapy

SOUTH SAN FRANCISCO, Calif., Jan. 30, 2020 /PRNewswire/ — VistaGen Therapeutics (NASDAQ: VTGN), a clinic… […]

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Mereo BioPharma and Oncologie Enter into Global Licensing Agreement for Navicixizumab

Oncologie receives exclusive global license to develop and commercialize navicixizumab

LONDON and REDWOOD CITY, Calif. and BOSTON, Jan. 13, 2020 /PRNewswire/ — Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), “Mereo” or the “Company,” and Oncolo… […]

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Mereo BioPharma and Oncologie Enter into Global Licensing Agreement for Navicixizumab

Oncologie receives exclusive global license to develop and commercialize navicixizumab

LONDON and REDWOOD CITY, Calif. and BOSTON, Jan. 13, 2020 /PRNewswire/ — Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), “Mereo” or the “Company,” and Oncolo… […]

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U.S. FDA Grants VistaGen Therapeutics Fast Track Designation for PH94B for Treatment of Social Anxiety Disorder

VistaGen’s PH94B is the first drug candidate to be granted U.S. FDA Fast Track designation for treatment of social anxiety disorder

SOUTH SAN FRANCISCO, Calif., Dec. 10, 2019 /PRNewswire/ — VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a clinical-sta… […]

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Kindred Biosciences Receives FDA Approval of Zimeta(TM) (dipyrone injection) for the Control of Pyrexia in Horses

SAN FRANCISCO, Nov. 25, 2019 /PRNewswire/ — Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that the U.S. Food and Drug Administration’s Center for Veterinary M… […]

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FDA Approves Medicines360’s LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Six Years, the Longest Approved Duration of Use of Any Hormonal IUDs

SAN FRANCISCO and DUBLIN, Oct. 28, 2019 /PRNewswire/ — Medicines360, a global nonprofit organization with a mission to expand women’s access to quality medicines, and Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced that… […]

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THINK Surgical Receives FDA Clearance to Market Active Robot for Total Knee Replacement Procedures in the United States

Approval follows multi-center investigational clinical trial evaluating safety and efficacy of TSolution One® Total Knee Application

FREMONT, Calif., Oct. 9, 2019 /PRNewswire/ — THINK Surgical, Inc. is pleased to announce it has obtained clearance f… […]

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Nektar Therapeutics and Bristol-Myers Squibb Announce U.S. FDA Breakthrough Therapy Designation for Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab) for the Treatment of Patients with Untreated Advanced Melanoma

SAN FRANCISCO, Aug. 1, 2019 /PRNewswire/ — Nektar Therapeutics (Nasdaq: NKTR) and Bristol-Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for investigational age… […]