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BioMarin Receives Positive CHMP Opinion in Europe to Expand Use of VOXZOGO® (vosoritide) to Treat Children Aged 4 Months and Older with Achondroplasia

September 15, 2023

European Commission Approval Decision Expected Q4 2023 Opinion Based on Positive Results from Global Phase 2 and Ongoing Extension Study U.S. Food and Drug Administration PDUFA Target Action Date...

Sachsen Anhalt United States Traci Mccarty Klaus Mohnike Andrew Villani Hank Fuchs

Source: marketscreener.com

BioLineRx Reports Second Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates

August 30, 2023

- On Track for September 9, 2023 PDUFA Target Action Date on NDA for Motixafortide in Stem Cell Mobilization (SCM) for Autologous Transplantation in Multiple...

United States John Lacey Philip Serlin Moran Meir Columbia University American Society Of Clinical Oncology

Source: prnewswire.com

Chatting With Charlie: August Visa Bulletin Update - Work Visas

July 21, 2023

During our May and June webinars Charlie predicted many of the retrogressions which have occurred for August's visa bulletin update. Below we will summarize the August Visa Bulletin...

August Visa Bulletin Final Action Date All Chargeability Action Date Application Filing Dates Chatting With Charlie August Visa Bulletin Update

Source: mondaq.com

BioLineRx Reports First Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates

May 24, 2023

/PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, today reported its unaudited...

United States John Lacey Philip Serlin Moran Meir Washington University School Of Medicine Lifesci Advisors

Source: prnewswire.com

Intercept Announces Outcome of FDA Advisory Committee Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH

May 20, 2023

20.05.2023 - 12 of 16 voting-eligible advisors vote “no” (with two abstentions) on question, “given the available efficacy and safety data, do the benefits of OCA 25 mg outweigh the risks in NASH patients with stage 2 or 3 fibrosis?” 15 of 16 voting-eligible ... Seite 1

Jerry Durso Intercept Pharmaceuticals Inc Drug Administration Company New Drug Application Gastrointestinal Drugs Advisory Committee Action Date

Source: wallstreet-online.de

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FDA Committee Votes Against Risk-Benefit Profile of OCA 25 mg for NASH

May 20, 2023

The June 22, 2023 PDUFA date for obeticholic acid 25 mg oral tablets for the treatment of precirrhotic liver fibrosis appears to be in jeopardy after a May 23, 2023 meeting of the FDA's Gastrointestinal Drugs Advisory Committee.

Jerry Durso Intercept Pharmaceuticals Meeting Of The Gastrointestinal Drugs Advisory Committee Drug Administration Intercept Pharmaceuticals Inc Gastrointestinal Drugs Advisory Committee

Source: hcplive.com

BioMarin Provides Update on FDA Review of ROCTAVIAN™ (Valoctocogene Roxaparvovec) Gene Therapy for Adults with Severe Hemophilia A

March 7, 2023

/PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today...

Hank Fuchs Marni Kottle Traci Mccarty Development Of Biomarin European Commission Drug Administration

Source: prnewswire.com

FDA Accepts BioMarin's Supplemental New Drug Application to Expand Use of VOXZOGO® (vosoritide) for Injection to Treat Children with Achondroplasia Under the Age of 5

March 7, 2023

/PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery,...

United States Hank Fuchs Marni Kottle Traci Mccarty Drug Administration Biomarin Pharmaceutical Inc

Source: prnewswire.com

BioMarin Announces Incremental Progress on Biologics License Application (BLA) Review for Valoctocogene Roxaparvovec AAV Gene Therapy for Adults with Severe Hemophilia A Program

November 7, 2022

/PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today a progress update on its Biologics License Application (BLA) for valoctocogene...

Hank Fuchs Debra Charlesworth Traci Mccarty European Commission Drug Administration Biomarin Pharmaceutical Inc

Source: prnewswire.com