FDA Approves PENBRAYA™, the First and Only Vaccine for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PENBRAYA™ (meningococcal…
European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin,…
.S. FDA Approves Pfizer’s VELSIPITY™ for Adults with Moderately to Severely Active Ulcerative Colitis (UC) Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved VELSIPITY™ (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor…
U.S. FDA Approves Pfizer’s BRAFTOVI® + MEKTOVI® for BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for the treatment of adult patients…
GEDi Cube and Renovaro Biosciences Sign Definitive Agreement to Combine‘ GEDi Cube Intl Ltd. (GEDi Cube), an AI medical technology company, and Renovaro Biosciences Inc. (NASDAQ:RENB) (Renovaro), an advanced, preclinical biotechnology firm in cell, gene and immunotherapy, have signed a…
Quizartinib Recommended for Approval in EU by CHMP for Patients with Newly Diagnosed FLT3-ITD Positive AML Daiichi Sankyo announced that quizartinib has been recommended for approval in the European Union (EU) in combination with standard cytarabine and anthracycline induction and standard…
EBGLYSS® (lebrikizumab) Receives Positive CHMP Opinion for Moderate-to-severe Atopic Dermatitis The positive CHMP opinion is now being reviewed by the European Commission (EC). The approval of this biologic in the European Union is expected in approximately two months and its launch…
European Commission approves Roche’s Evrysdi for babies under two months old with spinal muscular atrophy Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved the extension of the Evrysdi® (risdiplam) European Union (EU) marketing authorisation…
Sandoz receives FDA approval for Tyruko first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis Sandoz, a global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has approved its biosimilar…
Lilly’s Retevmo®Demonstrates Superior Progression-Free Survival Compared to Approved Multikinase Inhibitors in RET-Mutant Medullary Thyroid Cancer Eli Lilly and Company (NYSE: LLY) today announced topline results from the LIBRETTO-531 study evaluating Retevmo versus the physician’s choice of the multikinase inhibitors (MKIs) cabozantinib…
U.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Infants Through Active Immunization of Pregnant Individuals 32-36 Weeks of Gestational Age Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration…
European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab) The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted the approval of a Type II variation application for TECVAYLI®▼ (teclistamab), providing the…
