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
Eli Lilly has become the first drugmaker to reach a $1?trillion market valuation, driven by soaring demand for its weight?loss and diabetes drugs. This ascension is indicative of how the weight-loss drug market, which was initially a niche, has...
The FDA is investigating Takeda’s Adzynma after a pediatric patient died following the development of neutralizing antibodies. The probe focuses on post-marketing safety signals and potential risks linked to immunogenicity in cTTP treatment.
Royal Philips, a worldwide frontrunner in health technology, revealed a prolonged collaboration with Cortechs.ai, an innovator in quantitative neuroimaging solutions. The companies will collaborate to incorporate Cortechs.ai’s cutting-edge AI-driven
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