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  • Alembic Partner NATCO Gets USFDA Tentative Approval Olaparib Tablets
    20 July 2026

    Alembic Partner NATCO Gets USFDA Tentative Approval Olaparib Tablets

    Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

    Alembic Pharmaceuticals Limited (Alembic) today announced that its Partner NATCO Pharma Limited (NATCO) has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Olaparib Tablets, 100 mg and 150 mg. 

  • India Approves First Dengue Vaccine : DCGI Clears Takeda's QDENGA for People Aged 4-60 Years
    20 July 2026
    India Approves First Dengue Vaccine : DCGI Clears Takeda's QDENGA for People Aged 4-60 Years

    In a landmark development for dengue prevention, the Drug Controller General of India (DCGI) has granted market authorization to Takeda Biopharmaceuticals India's QDENGA (Dengue Tetravalent Vaccine [Live, Attenuated]), making it the first dengue vaccine approved in India. The vaccine is approved for the prevention of dengue in individuals 4 to 60 years of age and can be administered regardless of prior dengue infection, eliminating the need for pre-vaccination screening.

  • Johnson & Johnson Reports Strong Q2 2026 Results, Raises Full-Year Outlook
    18 July 2026
    Johnson & Johnson Reports Strong Q2 2026 Results, Raises Full-Year Outlook
    Johnson & Johnson has reported strong financial results for the second quarter of 2026, driven by continued growth across its Innovative Medicine and MedTech businesses.
  • FDA Issues Form 483 to Catalent Indiana Over Sterile Drug Manufacturing Concerns
    18 July 2026
    FDA Issues Form 483 to Catalent Indiana Over Sterile Drug Manufacturing Concerns
    The U.S. Food and Drug Administration, FDA has issued a Form FDA 483 to Catalent Indiana LLC. The inspection identified multiple observations related to quality systems, contamination control, investigations, and sterile manufacturing practices at the facility.
  • CDSCO Panel Rejects Dexlansoprazole–Domperidone FDC Proposal
    17 July 2026
    CDSCO Panel Rejects Dexlansoprazole–Domperidone FDC Proposal

    The Subject Expert Committee (SEC) on Gastroenterology and Hepatology has declined to recommend approval of a Fixed Dose Combination (FDC) containing Dexlansoprazole (enteric coated pellets) 60 mg and Domperidone (sustained release pellets) 30 mg capsules proposed by MSN Laboratories Private Limited.

    The decision was taken during the 08th/26 SEC meeting held on 9 July 2026 at the CDSCO Headquarters, New Delhi, after the company presented its proposal before the committee.

  • FDA Clears First Daily Oral PCSK9 Pill for High Cholesterol
    17 July 2026
    FDA Clears First Daily Oral PCSK9 Pill for High Cholesterol

    Merck has announced that the US Food and Drug Administration (FDA) has approved LIPFENDRA® (enlicitide) 20 mg, making it the first and only once-daily oral PCSK9 inhibitor for lowering low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). The approval marks the first oral alternative to injectable PCSK9 inhibitors.

  • FDA Grants Full Approval to Novartis' Fabhalta for IgA Nephropathy
    17 July 2026
    FDA Grants Full Approval to Novartis' Fabhalta for IgA Nephropathy

    Novartis has announced that the US Food and Drug Administration (FDA) has granted traditional approval to Fabhalta® (iptacopan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The decision follows the drug's accelerated approval in August 2024, which was based on its ability to reduce proteinuria.

  • New Meta-Analysis Questions Routine Vitamin D Supplementation During Pregnancy to Prevent Preterm Birth
    16 July 2026
    New Meta-Analysis Questions Routine Vitamin D Supplementation During Pregnancy to Prevent Preterm Birth

    A comprehensive systematic review and meta-analysis published in the journal BIO Integration has found that routine vitamin D supplementation during pregnancy does not provide convincing evidence for preventing preterm birth. The analysis also highlighted that an apparent increase in preterm birth risk observed in one subgroup should be interpreted with caution because it was driven by a single clinical trial involving women living with HIV, rather than the broader pregnant population.

  • Gujarat State Pharmacy Council and IPC Launch Dedicated Pharmacovigilance & Medicine Safety Portal
    16 July 2026
    Gujarat State Pharmacy Council and IPC Launch Dedicated Pharmacovigilance & Medicine Safety Portal

    The Gujarat State Pharmacy Council (GSPC) has partnered with the Indian Pharmacopoeia Commission (IPC) to launch a dedicated "Pharmacovigilance & Medicine Safety" to strengthen medicine safety awareness and promote adverse drug reaction (ADR) reporting

  • European Commission Approves Novo Nordisk's Oral Wegovy, Marking New Era in Obesity Treatment
    16 July 2026
    European Commission Approves Novo Nordisk's Oral Wegovy, Marking New Era in Obesity Treatment

    Novo Nordisk has announced that the European Commission (EC) has approved Wegovy® (semaglutide) tablets for chronic weight management, making it the first oral GLP-1 receptor agonist authorized in the European Union for the treatment of obesity and overweight. The approval also includes a single, ready-to-use 7.2 mg Wegovy injection pen, providing healthcare professionals and patients with additional treatment options.

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