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  • Zydus Lifesciences delivers steady growth in Q1 FY26, boosted by global expansion

    Zydus Lifesciences Limited reported a steady performance for the quarter ended June 30, 2025, with growth across key geographies and strong contributions from innovation-driven initiatives. The pharmaceutical major posted revenue from operations of Rs. 65,737 million, marking a 6% increase year-on-year and a marginal 0.7% rise from the previous quarter. Net profit stood at Rs. 14,668 million, up 3% from the same quarter last year and a robust 25.3% higher than Q4 FY25.

  • Indoco Remedies receives final ANDA approval from USFDA for Rivaroxaban Tablets
    Indoco Remedies Ltd. announced final approval of the Company Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg and 20 mg, to market a generic equivalent to the reference listed drug (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen), from USFDA.
  • Bayer and Kumquat Biosciences enter global exclusive license and collaboration in precision oncology
    Bayer and Kumquat Biosciences Inc., a clinical-stage biotech company founded by pioneers of the KRAS pathway, today announced that they have entered into an exclusive global license and collaboration to develop and commercialize Kumquats KRAS G12D inhibitor.
  • Valneva announces Removal of FDA-Recommended Pause on Use of Chikungunya Vaccine IXCHIQ®
    Valneva SE announced that the FDA has removed its recommended pause in the use of IXCHIQ in individuals 60 years of age and older and has approved updates to the Prescribing Information for IXCHIQ.
  • Cormedix to acquire Melinta Therapeutics
    CorMedix Inc. a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, and Melinta Therapeutics LLC, a private commercial-stage company providing innovative therapies for acute and life-threatening illnesses announced a definitive agreement for CorMedix to acquire Melinta.
  • LENZ Therapeutics announces USFDA approval of VIZZ for the Treatment of Presbyopia

    LENZ Therapeutics, Inc announced the US Food and Drug Administration approved VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults. Samples are anticipated in the United States as early as October 2025, with commercial product to be broadly available by mid-Q4 2025. Direct-to-eye care professional sales and marketing activities to be initiated immediately.

  • AbbVie's RINVOQ® Shows Promising Results in Phase 3 Trial for Severe Alopecia Areata
    AbbVie announced positive topline results from the first of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 83.8 (approximately 16% scalp hair coverage).
  • Trump Sends Ultimatum to Big Pharma : Slash Drug Prices or Face Action
    US President Donald J. Trump has issued a sweeping ultimatum to 17 of the worlds largest pharmaceutical companies, demanding they drastically lower drug prices for Americans within 60 days or face aggressive regulatory and trade action.
  • NATCO Pharma’s Mekaguda API unit receives EIR from U.S. FDA following June inspection
    NATCO Pharmas Active Pharmaceutical Ingredient (API) facility located in Mekaguda, near Hyderabad, has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration
  • Zydus receives tentative USFDA approval for Ibrutinib tablets in multiple strengths
    Zydus Lifesciences Limited has received tentative approval from the U.S. Food and Drug Administration (USFDA) to market Ibrutinib tablets in three strengths — 140 mg, 280 mg, and 420 mg. The approved products are generic versions of Imbruvica®, a widely used cancer medication in the United States.
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