Regulatory Affairs

Regulatory Affairs

Incyte Announces U.S. FDA Approval of Opzelura™ (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD)

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream for the short-term and non-continuous...

Admin - September 22, 2021

Regulatory Affairs

Incyte Announces FDA Approval of Jakafi® (ruxolitinib) for Treatment of Chronic Graft-Versus-Host Disease (GVHD)

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for treatment of chronic graft-versus-host disease...

Admin - September 22, 2021

Regulatory Affairs

Seagen and Genmab Announce FDA Accelerated Approval for TIVDAK™ (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer

BOTHELL, Wash. & COPENHAGEN, Denmark--(BUSINESS WIRE)--Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA)...

Admin - September 21, 2021

Regulatory Affairs

Accutar Biotechnology Announces FDA Clearance of IND Application for Phase 1 Trial of AC0682 in ER-Positive Breast Cancer

BROOKLYN, N.Y.--(BUSINESS WIRE)--Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, today announced that the U.S. Food and Drug Administration...

Admin - September 21, 2021

Regulatory Affairs

Emergency Use Authorization of AbCellera-Discovered Bamlanivimab Administered with Etesevimab Expanded by the FDA to Include Post-Exposure Prophylaxis for the Prevention of COVID-19

VANCOUVER, British Columbia--(BUSINESS WIRE)--AbCellera (Nasdaq: ABCL) today announced the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab...

Admin - September 17, 2021

Regulatory Affairs

Takeda’s EXKIVITY™ (mobocertinib) Approved by U.S. FDA as the First Oral Therapy Specifically Designed for Patients with EGFR Exon20 Insertion+ NSCLC

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has approved EXKIVITY...

Admin - September 16, 2021

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Recent Articles

Lilly to Supply the EU and EEA with up to 220,000 Doses of AbCellera-Discovered Bamlanivimab Together with Etesevimab for the Treatment of Confirmed COVID-19

Incyte Announces U.S. FDA Approval of Opzelura™ (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD)

bluebird bio Submits Biologics License Application (BLA) to FDA for betibeglogene autotemcel (beti-cel) Gene Therapy for Patients With β-thalassemia Who Require Regular Red Blood...

LabGenius Appoints Dr. Didier Landais as Chief Operating Officer

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Dicerna Announces New Executive Leadership Appointments

Ferring to Present Award-Winning, Landmark Research for Investigational Microbiota-Based Live Biotherapeutic RBX2660 at IDWeek 2021

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Peptilogics to Present First-in-Human Phase 1 Clinical Data of PLG0206 at IDWeek 2021