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Regulatory Affairs

 Qihan Biotech Expands Scientific Advisory Board and Establishes Scientific Advisory Committees

HANGZHOU, China--(BUSINESS WIRE)--Qihan Biotech announced the expansion of its Scientific Advisory...

CytRx Issues Statement Regarding Orphazyme’s Global Offering

LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (OTCQB:CYTR) (“CytRx” or the “Company”), a specialized...

Lantheus Holdings Submits New Drug Application to the U.S. FDA for PyL™ (18F-DCFPyL), a PSMA-Targeted Prostate Cancer Imaging Agent

NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the...

Bayer’s XtendFlex Soybeans Gain Final Key Regulatory Approval

ST. LOUIS--(BUSINESS WIRE)--Bayer announced today that the European Commission has authorized...

Health Canada Approves REBLOZYL® (luspatercept), New Class of Treatment for Adult Patients Living with Beta Thalassemia

MONTREAL & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Bristol Myers Squibb Canada (BMS) and Acceleron...

Orb Health Names Healthcare Visionary Entrepreneur and Investor Sheila Schweitzer to Board of Directors

RICHARDSON, Texas.--(BUSINESS WIRE)-- #aco--Orb Health, the leader in Chronic Care Management...

U.S. FDA Approves Pfizer’s XELJANZ® (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that the United...

Infinity Receives Fast Track Designation for Eganelisib in Combination with a Checkpoint Inhibitor and Chemotherapy for First-Line Treatment of Advanced TNBC

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) announced today that the...

FDA Grants Organicell Expanded Access to Treat COVID-19 Patients with Zofin™

MIAMI--(BUSINESS WIRE)--FDA Grants Organicell Expanded Access to Treat COVID-19 Patients with...

AVROBIO Receives Orphan Drug Designation from the European Medicines Agency for AVR-RD-02, an Investigational Gene Therapy for Gaucher Disease

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AVRO--AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene...

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