Category Regulatory

IDE034, a Bispecific Antibody-Drug Conjugate Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance

IDE034, a Bispecific Antibody-Drug Conjugate Licensed by Biocytogen to IDEAYA, Secures FDA IND Clearance Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of…

Read MoreIDE034, a Bispecific Antibody-Drug Conjugate Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance

Aetna Enhances Efforts to Streamline Experiences for Healthcare Professionals and Patients

Aetna Accelerates National Strategy to Simplify Healthcare for Providers and Patients Through Innovation, AI, and Integrated Care Models Aetna®, a CVS Health® company today announced significant progress on its ambitious, system-wide initiative to eliminate friction across the U.S. healthcare ecosystem—a…

Read MoreAetna Enhances Efforts to Streamline Experiences for Healthcare Professionals and Patients

FDA Grants Priority Review to Baxdrostat New Drug Application for Hard-to-Control Hypertension in the U.S.

FDA Grants Priority Review to AstraZeneca’s Baxdrostat for Hard-to-Control Hypertension—A Potential First-in-Class Therapy In a significant milestone for cardiovascular innovation, the U.S. Food and Drug Administration (FDA) has accepted AstraZeneca’s New Drug Application (NDA) for baxdrostat under Priority Review, signaling…

Read MoreFDA Grants Priority Review to Baxdrostat New Drug Application for Hard-to-Control Hypertension in the U.S.

EU Approves Johnson & Johnson’s IMAAVY® (nipocalimab) for Broad gMG Patients, Enabling Long-Term Disease Control

Johnson & Johnson Secures European Commission Approval for IMAAVY® (nipocalimab)—A Groundbreaking FcRn Blocker for Generalised Myasthenia Gravis In a landmark development for the treatment of generalized myasthenia gravis (gMG), Johnson & Johnson IMAAVY has announced that the European Commission (EC)…

Read MoreEU Approves Johnson & Johnson’s IMAAVY® (nipocalimab) for Broad gMG Patients, Enabling Long-Term Disease Control

Latus Bio Receives IND Clearance and Key FDA Designations for LTS-101 in CLN2 Disease

Latus Bio Achieves Major Regulatory Milestone with IND Clearance and Triple FDA Designations for LTS-101 in CLN2 Disease Latus Bio, Inc., a clinical-stage biotechnology company at the forefront of adeno-associated virus (AAV) gene therapy innovation, has announced a significant advancement…

Read MoreLatus Bio Receives IND Clearance and Key FDA Designations for LTS-101 in CLN2 Disease

TeamBest Global Issues Open Letter to AROI on Affordable Cancer and Vascular Care

TeamBest Global Calls for Stronger Collaboration with AROI to Advance Affordable Cancer and Vascular Disease Care in India and Worldwide Dr. Krishnan Suthanthiran, along with his TeamBest Global family of companies—widely recognized for pioneering cost-effective medical technologies for the diagnosis…

Read MoreTeamBest Global Issues Open Letter to AROI on Affordable Cancer and Vascular Care
Cardiovascular

Corstasis and Cardiovascular Logistics Partner to Advance Outpatient Heart Failure Care

Corstasis Partners with Cardiovascular Logistics to Redefine Heart Failure Treatment Corstasis Therapeutics Inc., a commercial-stage biopharmaceutical company focused on advancing patient-centric, outpatient treatment strategies for cardiovascular and renal disorders, today announced a strategic collaboration with Cardiovascular Logistics (CVL). This collaboration…

Read MoreCorstasis and Cardiovascular Logistics Partner to Advance Outpatient Heart Failure Care

Real-World Evidence Confirms Repatha’s Sustained Cardiovascular Benefits

Real-World Study Shows Durable Cardiovascular Protection with Repatha Target RWE, a leading organization in modern real-world evidence (RWE) generation and a trusted partner for regulatory-grade research, has announced significant new findings from the REPATHA-CE study—now recognized as the largest real-world…

Read MoreReal-World Evidence Confirms Repatha’s Sustained Cardiovascular Benefits

Zetagen Therapeutics Raises Oversubscribed Series B1 Round

Zetagen Therapeutics Announces Oversubscribed $12.9M Series B1 Financing to Advance Breakthrough Intratumoral Therapies for Breast Cancer Zetagen Therapeutics, Inc., a privately held clinical-stage biopharmaceutical company advancing first-in-class intratumoral therapies for metastatic and primary breast cancer, today announced the successful completion…

Read MoreZetagen Therapeutics Raises Oversubscribed Series B1 Round