EU Nods Pfizer’s Velsipity® for Ulcerative Colitis
Pfizer Inc. announced that the European Commission has approved VELSIPITY® (etrasimod) for the treatment of patients aged 16 and...
Jon Napitupulu
Datopotamab Deruxtecan BLA Accepted for US Lung Cancer
Daiichi Sankyo and AstraZeneca’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the U.S. FDA...
Tagrisso & Chemo Combo Approved in US for EGFR Lung Cancer
AstraZeneca’s TAGRISSO® (osimertinib), in combination with chemotherapy, has been approved in the US for the treatment of adult patients...
FDA OKs Xolair as Sole Drug for Multi-Food Allergies
Genentech, a member of the Roche Group, has announced the FDA approval of Xolair® (omalizumab) for reducing allergic reactions,...
Gilead Boosts Liver Portfolio by Acquiring CymaBay
Gilead Sciences, Inc. has agreed to acquire CymaBay Therapeutics, Inc. for $4.3 billion, expanding its portfolio with seladelpar, a...
Takeda’s EoE Drug Eohilia Gets First FDA Approval in US
Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved EOHILIA (budesonide oral suspension) for the...
Takeda’s TAK-861 Narcolepsy Phase 3 Trials Set for FY2024
Takeda has announced promising topline results from a Phase 2b trial evaluating TAK-861, an oral orexin receptor 2 (OX2R)...
Survey: Pharma Fears CRO Instability Amid Sector Mergers
Worldwide Clinical Trials has released a survey report on the perceptions of large and midsize contract research organizations (CROs)...
BMS’s Opdivo for Lung Cancer: US & EU Filings Accepted
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics Application (sBLA)...
AstraZeneca Grows US Cell Therapy Production Capacity
AstraZeneca has announced a $300 million investment in a new state-of-the-art facility in Rockville, Maryland, aimed at advancing its...