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  • Trodelvy Gains Simultaneous US FDA and EU Approval as First-Line Treatment for Metastatic Triple-Negative Breast Cancer

    Gilead Sciences has achieved a major milestone in breast cancer treatment as Trodelvy® (sacituzumab govitecan-hziy) received approvals from both the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for use as a first-line therapy in metastatic triple-negative breast cancer
  • WHO Moves to Establish Global Standards for Herbal Medicines Through International Pharmacopoeia Initiative

    The World Health Organization (WHO) has taken another significant step toward strengthening the quality, safety, and regulation of herbal medicines by advancing the development of an International Herbal Pharmacopoeia (IHP). During the 5th WHO Expert Meeting held in Hong Kong SAR (China) from 16–18 June 2026, experts from all six WHO regions met to accelerate the creation of globally harmonized standards for herbal medicines.

  • EU Invests 15 Million euro in Phage Therapy Research to Combat Recurrent Urinary Tract Infections

    The European Union has awarded 15 million euro under its Horizon Europe research and innovation program to launch REPhRAME, an ambitious international project aimed at developing a new treatment strategy for recurrent urinary tract infections (UTIs). Coordinated by Universitätsmedizin Frankfurt under the leadership of Prof. Dr. Maria J.G.T. Vehreschild, the five-year project will evaluate phage therapy as a potential alternative to antibiotics in patients suffering from recurrent bacterial infections.

  • Sun Pharma Expands Healthcare Portfolio with ₹271 Crore Acquisition of Innovcare Lifesciences

    Sun Pharmaceutical Industries Ltd. has announced the acquisition of Innovcare Lifesciences Private Limited. The deal, valued at approximately ₹271.2 crore, will give Sun Pharma complete ownership of the Mumbai-based healthcare company.

  • CDSCO Panel Seeks Revisions in Emcure’s Post-Marketing Study Plan for Liposomal Amphotericin B Injection

    The Subject Expert Committee (SEC) on Antimicrobial & Antiparasitic has asked M/s Emcure Pharmaceuticals Limited to revise its proposed Active Post-Marketing Surveillance (PMS) protocol for Liposomal Amphotericin B Injection 50 mg/vial (Lyophilized) before it can be considered further.

    The recommendation was made during the 6th SEC (Antimicrobial & Antiparasitic) meeting of 2026, held on June 11, 2026, at the Central Drugs Standard Control Organization (CDSCO) headquarters in New Delhi.

  • Kemwell Biopharma Gets CDSCO Panel Nod for Clinical Study of Dupilumab Biosimilar ASP100

    In a significant development in the biosimilar segment, the Subject Expert Committee (SEC) on Dermatology & Allergy has recommended granting permission to M/s Kemwell Biopharma Private Limited to conduct a comparative pharmacokinetic clinical study for its proposed Dupilumab biosimilar, ASP100.

    The recommendation was made during the 6th SEC (Dermatology & Allergy) meeting of 2026, held on June 11, 2026, at the CDSCO Headquarters in New Delhi.

  • Alembic Gains Strategic Edge in US Oncology Market with Tentative Approval for Binimetinib 45 mg Tablets

    Alembic Pharmaceuticals Limited has announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg. The company had earlier secured tentative approval for the 15 mg strength of the same drug.

    The approved generic product is therapeutically equivalent to Mektovi Tablets, 15 mg, marketed by Array BioPharma. Binimetinib is a kinase inhibitor used in combination with encorafenib for the treatment of patients with specific forms of advanced cancer.

  • Aurobindo Clears Major Regulatory Hurdle in Lannett Acquisition, Agrees to Divest Four Products

    Aurobindo Pharma has successfully moved one step closer to completing its strategic acquisition of U.S.-based generic drug manufacturer Lannett Company after the U.S. Federal Trade Commission (FTC) approved the transaction subject to certain divestiture conditions.

    The FTC announced that Aurobindo will divest four generic pharmaceutical products to Quagen Pharmaceuticals as part of a consent agreement designed to preserve competition in the U.S. generic medicines market. With this requirement in place, the proposed acquisition of Lannett can move forward toward completion.

  • GSK Makes 10.6 Billion USD Oncology Bet with Acquisition of Nuvalent

    GSK has announced an agreement to acquire Nuvalent, a clinical-stage biotechnology company focused on precision cancer therapies, in a transaction valued at approximately 10.6 billion USD. The deal significantly strengthens GSK's oncology pipeline and expands its presence in the rapidly growing lung cancer treatment market.

  • Eisai Bets on UK Growth with New Cold-Chain Manufacturing Expansion

    Eisai has announced a significant investment in its manufacturing facility in Hatfield, United Kingdom, aimed at expanding its capabilities for medicines that require specialized cold-chain storage and transportation. The project is being supported by the UK Government through the Life Sciences Innovative Manufacturing Fund (LSIMF).

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