CDC Officially Endorses Delayed Hepatitis B Vaccine Schedule
CDC Officially Approves Delayed Hepatitis B Vaccine Dose The CDC has accepted the recommendation of its vaccine advisory committee and ended the three-decade-long practice of giving most newborn children a birth dose…
BlueRock’s Parkinson’s Cell Therapy Gets Japan’s Pioneering Regenerative Designation
BlueRock Therapeutics’ Investigational Cell Therapy Bemdaneprocel for Parkinson’s Disease Granted Pioneering Regenerative Medical Product Designation in Japan Bayer AG and its wholly owned, independently operated subsidiary BlueRock Therapeutics LP, a…
KEYTRUDA + Padcev Boost Survival and Response in Cisplatin-Eligible MIBC Patients Around Surgery
KEYTRUDA® Combined with Padcev® Significantly Boosts Event-Free Survival, Overall Survival, and Pathologic Complete Response Rates in Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer When Administered Perioperatively Merck, known as MSD outside…
U.S. FDA Approves RYBREVANT FASPRO™—Shortest First-Line Infusion with LAZCLUZE®
U.S. FDA Approves RYBREVANT® FASPRO™ (amivantamab and hyaluronidase-lpuj), Offering the Shortest and Simplest Administration Time for a First-Line Combination Regimen with LAZCLUZE® (lazertinib) Johnson & Johnson announced today that the…
Grifols Secures European Medicines Agency Approval for Full Value Chain of Grifols Egypt
Grifols Secures European Medicines Agency Approval for Grifols Egypt’s Full Value Chain Grifols, S.A., a global leader in plasma-derived medicines and innovative healthcare solutions, has received certification from the European…
Argenx Updates on UplighTED Clinical Trials of Efgartigimod SC for Thyroid Eye Disease
Argenx Shares Update on UplighTED Clinical Trials of Subcutaneous Efgartigimod for Thyroid Eye Disease Argenx SE, a global immunology company committed to improving the lives of people suffering from severe…
UK Approves Exdensur (Depemokimab) for Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps
Exdensur (depemokimab) Approved in the UK for Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps GSK plc today announced the marketing authorisation of Exdensur (depemokimab) by the UK’s Medicines…
Zoetis Proposes $1.75 Billion Convertible Senior Notes Offering
Zoetis Launches Proposed $1.75 Billion Offering of Convertible Senior Notes Zoetis Inc. today announced that, subject to market conditions, it intends to offer $1.75 billion aggregate principal amount of convertible…
Enhertu + Pertuzumab Approved as First New 1L Treatment in 10 Years for HER2+ Metastatic Breast Cancer
Enhertu plus pertuzumab approved in the U.S. as the first new first-line treatment in a decade for HER2-positive metastatic breast cancer AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab…
Cytokinetics Announces Positive CHMP Opinion for MYQORZO®
Cytokinetics Announces Positive CHMP Opinion for MYQORZO® in Obstructive HCM Cytokinetics, Incorporated today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)…
Aflibercept 8 mg Recommended for EU Approval for Third Retinal Indication
Aflibercept 8 mg Recommended for EU Approval for Third Retinal Indication The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended aflibercept 8…
Merck Gains Positive EU CHMP Opinion for WINREVAIR™ Expansion in PAH
Merck Receives Positive CHMP Opinion in the EU for Expanded Use of WINREVAIR™ (sotatercept) in Adults with Pulmonary Arterial Hypertension (PAH; WHO Group 1 Pulmonary Hypertension) Merck, known as MSD…