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  • Lupin Receives Tentative Approval from USFDA for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets
    26 September 2025

    Lupin Receives Tentative Approval from USFDA for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets

    Global pharma major Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg. This product would be manufactured at Lupin’s Nagpur facility in India.

  • 26 September 2025
    Unitaid, CHAI, and Wits RHI enter into a landmark agreement with Dr. Reddy’s to make HIV prevention tool lenacapavir affordable in LMICs
    The revolutionary HIV prevention tool, injectable lenacapavir, will be available at a cost of USD 40 a year in 120 low- and middle-income countries starting in 2027, under a new partnership announced today between Dr. Reddy’s Laboratories and Unitaid, the Clinton Health Access Initiative (CHAI), and Wits RHI
  • 26 September 2025
    Systemically injectable therapy could prevent heart failure after a heart attack
    Scientists at Northwestern University and University of California San Diego have developed a new, potent injectable therapy that can protect the heart from damage after a heart attack.
  • 24 September 2025
    Montu Patel removed as PCI chief amid corruption allegations

    The Union Ministry of Health and Family Welfare has removed Montu Patel from his role as President of the Pharmacy Council of India (PCI), citing that he no longer meets the membership requirements to hold office, The Times of India reported.

    According to the ministry’s order, “Currently, Patel is neither a nominated member under Section 3(h) of the PCI Act, 1948, nor a member of the Gujarat State Pharmacy Council. Hence he ceases to be a member of the Central Council of PCI, thereby also ending his presidentship.”

  • 23 September 2025
    FDA rejects Otsuka and Lundbeck’s bid for REXULTI® in PTSD Treatment
    Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the supplemental New Drug Application (sNDA) for the use of REXULTI® (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD).
  • 23 September 2025
    FDA Grants Accelerated Approval to First Treatment for Barth Syndrome
    U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Barth syndrome is a rare, serious and life-threatening disease of the mitochondria.
  • 23 September 2025
    FDA moves to approve Leucovorin Calcium for rare neurological disorder linked to Autism

    The U.S. Food and Drug Administration (FDA) has taken a significant step forward in approving leucovorin calcium tablets for the treatment of cerebral folate deficiency (CFD) — a rare neurological condition that disrupts the transport of folate, a vitamin essential for brain development and function.

    Cerebral folate deficiency has been associated with developmental delays, seizures, coordination problems, and autistic features such as challenges in social communication, sensory issues, and repetitive behaviors.

  • 20 September 2025
    USFDA successfully completes inspection at Indoco’s API manufacturing facility at Patalganga with zero observations
    Indoco Remedies Limited announced that the United States Food and Drug Administration successfully completed inspection of its Active Pharmaceutical Ingredients (API) manufacturing facility at Patalganga, Navi Mumbai. The inspection concluded with zero form 483 observations, reflecting the company's commitment to the highest standards of quality, regulatory compliance and operational excellence.
  • 19 September 2025
    Stryker expands its R&D footprint in India with new facility in Bangalore
    Stryker a global leader in medical technologies, announced the expansion of its R&D presence in India with the opening of a new facility in Whitefield, Bengaluru. Building on its existing 220,000-square-foot R&D campus in Gurgaon, the new 140,000-square-foot facility further strengthens Stryker’s footprint in the country.
  • 18 September 2025
    Dr. Reddys launches novel molecule Tegoprazan in India
    Dr. Reddys Laboratories Ltd. announced the launch of the novel molecule Tegoprazan, for acid-related gastrointestinal diseases in India. Dr. Reddys launches Tegoprazan (50 mg) under the brand name PCAB.
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