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FDA Approves Oral Semaglutide by Novo Nordisk for CV Risk Reduction in Adults with Type 2 Diabetes
Rybelsus (Semaglutide) tablets, available in 7 mg and 14 mg doses, is the only FDA-approved oral GLP-1 therapy, and is now indicated to lower the risk of Major Adverse Cardiovascular Events (MACE)—including CV death, heart attack, or stroke—in adults with type 2 diabetes at high cardiovascular risk.
Merck Commits More Than USD 70 Billion to USA Manufacturing and R&D Expansion
A central component of this investment is the construction of a USD 3 billion pharmaceutical manufacturing facility in Elkton, Virginia, which is expected to generate around 500 permanent jobs and several thousand construction roles.
Strides to market Incepta's WHO-prequalified long-acting contraceptive in Africa
The product, branded as “Medogen SubQ”, is a three-monthly subcutaneous injectable version of depot medroxyprogesterone acetate (DMPA-SC) that can be administered by trained healthcare workers or self-injected after appropriate instruction.
USFDA Concludes Inspection at Dr. Reddy's Srikakulam Facility with VAI Classification
Dr. Reddy’s Laboratories has announced that the United States Food and Drug Administration (USFDA) has completed a Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI) at its formulations manufacturing facility (FTO 11) in Srikakulam, Andhra Pradesh.
Qure.ai launches world's first AI-powered paediatric TB screening tool
Qure.ai launches qXR, an AI-powered chest X-ray tool, CE Class IIb certified for diagnosing TB in children aged zero to three years, extending its coverage up to age of 15 years.
Aspire Pharma acquires Charlwood Pharma
Aspire Pharma, a UK-based specialty generics pharma business, has announced the acquisition of Charlwood Pharma Ltd — a privately-owned company specialising in the research and development of niche generic medicines. The deal marks the culmination of a successful multi-year collaboration between the two organisations.
FDA Approves Genentech's Gazyva for Treatment of Lupus Nephritis
The US Food and Drug Administration (FDA) has approved Gazyva (obinutuzumab), developed by Genentech, for the treatment of adults with lupus nephritis (LN), also known as lupus-related kidney disease.
Waters Corporation Unveils Xevo Charge Detection MS for Advanced Biomolecule Analysis
The new Xevo CDMS system by Waters Corporation enables measurement of large biomolecules to support Research and Development (R&D) in gene and protein-based therapies.
ACG Announces USD 200 Million Investment for Empty-Capsule Manufacturing In the US
ACG has announced a USD 200 million phased investment to establish its first empty-capsule manufacturing operations in the United States.
Alembic Pharmaceuticals Gets USFDA Nod for Triamcinolone Acetonide Injection
The approved ANDA, Triamcinolone Acetonide Injection, is therapeutically equivalent to the Reference Listed Drug (RLD) product, Kenalog-40 Injectable Suspension, of Bristol-Myers Squibb company.
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