Bayer reported a major step forward today as its experimental drug asundexian reduced the risk of recurrent ischemic stroke without increasing bleeding risk in a global phase III study. The OCEANIC-STROKE trial hit both its primary efficacy and...
The European Commission has approved the denosumab biosimilar AVT03 marketing. This license allows the Dr.?Reddy’s Laboratories to provide new options of treatment all over the EU and the European Economic Area...
Alkem Laboratories Ltd has introduced DSS, the original De Simone formulation probiotic mixture in India, aimed at restoring gut microbiota equilibrium and addressing several gut-related health issues.
Shilpa Medicare, Eight Observations, Unit IV, Jadcherla Telangana, Ten-Day Inspection, Sterile Injectables, Oral Tablets, Capsule Production, Regulatory Approvals, US Sales, Key Agencies, Consolidated Profit
The Central Drugs Standard Control Organisation (CDSCO) has informed procurement agencies, including hospitals, that a license from Indian licensing authorities must be obligatory for acquiring devices, with additional certifications required beyond
Roche has received conditional marketing approval in Europe for Lunsumio, a new subcutaneous form of its bispecific antibody that can be administered in a quick, one?minute injection. This approval marks one of the significant changes in the...
Solara Active Pharma Sciences Limited has announced that its multi-product API plant in Mangalore, Karnataka has cleared a recent US FDA inspection. The review took place from August 25 to 29, 2025, and the company confirmed today that the Agency...
Merck has secured a major win today as the US FDA approved KEYTRUDA and KEYTRUDA QLEX, used with Padcev, for adults with muscle-invasive bladder cancer (MIBC) who cannot receive cisplatin. This marks the first time a PD-1 inhibitor has been...
Tesaro, Inc., a GSK subsidiary, announces that it has filed a lawsuit against AnaptysBio, Inc. in the Delaware Chancery Court. This action asserts that recent behavior of AnaptysBio significantly violates the current licensing agreement with Tesaro
Abbott and Exact Sciences revealed a definitive agreement for Abbott to purchase Exact Sciences, allowing it to enter and take the lead in rapidly growing cancer diagnostics sectors, reaching millions more individuals
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