Potential First Approved Treatment in the EU Targeting NF1-Associated Plexiform Neurofibromas koselugo (selumetinib), an oral, selective MEK inhibitor, has been recommended for approval in the European Union (EU) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult patients with…
CHMP Recommends EU Approval of Tezspire for Chronic Rhinosinusitis with Nasal Polyps AstraZeneca and Amgen’s Tezspire (tezepelumab) has been recommended for approval in the European Union (EU) for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The Committee…
Merck Secures Dual Positive CHMP Opinions for KEYTRUDA® in Europe: Subcutaneous Administration and New Head & Neck Cancer Indication Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced a major regulatory milestone in Europe as…
Biogen Receives European Commission Approval for ZURZUVAE® (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted marketing authorization for ZURZUVAE® (zuranolone) to treat post-partum…
Deciphera Receives European Commission Approval of ROMVIMZA™ (vimseltinib) for the Treatment of Tenosynovial Giant Cell Tumor (TGCT) Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced that the European Commission (EC) has approved ROMVIMZA™…
Novo, Lilly Jostle For Market Lead in Obesity With New Regulatory Efforts Both Novo Nordisk and Eli Lilly are eyeing regulatory advancements for their obesity blockbusters as the European Association for the Study of Diabetes’ annual conference continues this week.…
EU approves first oral GLP-1 RA to cut cardiovascular risk Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the Rybelsus® (oral semaglutide) label to reflect the cardiovascular…
AGC Biologics Seattle Facility Celebrates Milestone Year with Regulatory Approvals, Quality Achievements, and Leadership Expansion AGC Biologics, a leading global contract development and manufacturing organization (CDMO), has announced that its Seattle, Washington facility has achieved a series of remarkable milestones…
France Grants Reimbursed Compassionate Access for Agenus’ Botensilimab plus Balstilimab in Refractory MSS Metastatic Colorectal Cancer In a significant development for patients with advanced colorectal cancer, Agenus Inc. (Nasdaq: AGEN), a biotechnology company at the forefront of immuno-oncology innovation, announced…
CyPath® Lung Demonstrates Diagnostic Power in Detecting Cancer Within Ground-Glass Nodules: A Case Study Highlighting bioAffinity Technologies’ Advancements in Noninvasive Lung Cancer Detection Lung cancer remains one of the deadliest forms of cancer worldwide, accounting for more deaths each year…
Corner Therapeutics Research Opens Door to Universal Flu Vaccine and Expands Promise for Cancer Immunotherapy Corner Therapeutics, a biotechnology company specializing in in vivo T cell modulation and immunotherapy, has announced groundbreaking findings that could reshape the future of vaccination…
Nature Medicine Publishes Phase 3 Data on Pridopidine, Offering Hope in Early-Stage Huntington’s Disease Prilenia Therapeutics B.V., a clinical-stage biopharmaceutical company specializing in neurodegenerative diseases, together with its partner Ferrer, announced a significant milestone in the scientific and medical understanding…