Last edition
News about
Indoco Receives USFDA EIR for Patalganga API Manufacturing Facility
Indoco has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration for its API manufacturing facility at Patalganga following an inspection conducted in the month of September.
Vektor Medical Secures FDA Clearance for Next-Generation vMap Arrhythmia Mapping Technology
Vektor Medical, a San Diego–headquartered medical technology company focused on advancing arrhythmia diagnosis and treatment, has received US Food and Drug Administration 510(k) clearance for its next-generation vMap technology.
Gaelic Laboratories Strengthens Manufacturing Footprint with Acquisition of Athlone Laboratories
Gaelic Laboratories, an Ireland-based manufacturer of beta-lactam (penicillin) products established in 2022, has acquired Athlone Laboratories, a long-standing developer and manufacturer of oral-dose beta-lactam medicines.
Orphalan announces acquisition of Orphelia Pharma
Orphalan has strengthened its leadership in rare diseases with the acquisition of Orphelia Pharma, expanding its global footprint and enhancing its portfolio of treatments for severe paediatric neurological and oncological conditions.
Lupin Manufacturing Solutions (LMS), a subsidiary of Lupin, has entered into a long-term strategic partnership with PolyPeptide Group AG, a global contract development and manufacturing organisation specialising in peptide-based active pharmaceutical ingredients.
Sovereign Pharma Commissions India's First High-Volume Isolator-Based Ampoule Manufacturing Line
Sovereign Pharma has commissioned its first isolator-based filling line as part of a long-term modernisation plan to upgrade three of its filling lines to advanced isolator systems. The newly commissioned line is fully operational and marks a major milestone in the company’s shift toward next-generation sterile manufacturing.
Platform Technologies Drive USD 211 Billion Surge in Precision Cancer Treatment
The rapid rise of platform technologies has added USD 211 billion in value to the precision oncology landscape, with immunotherapies now accounting for more than 45 percent of global anticancer drug revenues—underscoring strong investor confidence in biologically targeted treatment approaches.
US FDA Approves Uplizna for Adults with Generalised Myasthenia Gravis
The US FDA has approved Uplizna for adults with generalised myasthenia gravis, marking a significant advancement as the first and only CD19-targeted B-cell therapy for both anti-AChR and anti-MuSK antibody–positive patients, offering durable disease control with just twice-yearly dosing.
US FDA Approves Phase III Trial of Cadonilimab Against Nivolumab in Gastric Cancer
The FDA’s clearance enables a global phase III study evaluating Cadonilimab, in combination with chemotherapy, as a first-line option for HER2-negative, unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma, directly comparing its efficacy to standard chemotherapy with or without Nivolumab.
Cycle Pharmaceuticals to Acquire Applied Therapeutics
The acquisition positions Cycle Pharmaceuticals to strengthen its rare disease portfolio, adding Applied Therapeutics’ promising CNS-penetrant aldose reductase inhibitor, govorestat, which targets severe unmet needs in central nervous system metabolic disorders.
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy