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  • Takeda and Dr. Reddy’s Partner to Promote and Distribute QDENGA® in India’s Private Pediatric and Adult Market
    18 September 2026

    Takeda and Dr. Reddy’s Partner to Promote and Distribute QDENGA® in India’s Private Pediatric and Adult Market

    QDENGA®, across India’s private market for pediatric and adult vaccination in India. Subject to completion of applicable processes with local authorities, the vaccine is anticipated to become available in the first half of 2027.
  • FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
    18 September 2026
    FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
    Sanfilippo syndrome type A is a rare inherited disorder that primarily affects the brain and nervous system. Children with the condition can experience progressive loss of cognitive, language and other developmental abilities. Before this approval, there was no FDA-approved treatment specifically designed to address the underlying cause of MPS IIIA
  • Dr. Reddy’s Expands Lenacapavir Partnership With Gilead for Future HIV Prevention Access
    17 September 2026
    Dr. Reddy’s Expands Lenacapavir Partnership With Gilead for Future HIV Prevention Access

    Dr. Reddy’s Laboratories has expanded its collaboration with Gilead Sciences through a royalty-free, non-exclusive voluntary licensing agreement covering investigational once-yearly lenacapavir for HIV prevention. The agreement builds on the companies’ existing 2024 licensing arrangement for lenacapavir and is intended to support future manufacturing readiness, technology transfer and supply planning in licensed territories.

  • Sanofi to Transfer 20 Mature Medicines and 3 Manufacturing Sites to Cheplapharm in Strategic Partnership
    16 September 2026
    Sanofi to Transfer 20 Mature Medicines and 3 Manufacturing Sites to Cheplapharm in Strategic Partnership

    Sanofi and Cheplapharm have announced plans to establish a new strategic partnership focused on the management of mature medicines. Under the proposed agreement, Cheplapharm will take over 20 mature medicines and three Sanofi manufacturing sites worldwide, while Sanofi will receive a 26.4% equity stake in Cheplapharm.

  • GSK’s Shingrix Prefilled Syringe Approved in Japan for Shingles Prevention
    11 September 2026
    GSK’s Shingrix Prefilled Syringe Approved in Japan for Shingles Prevention

    GSK plc has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a prefilled syringe presentation of Shingrix (Recombinant Zoster Vaccine, RZV) for the prevention of shingles (herpes zoster). The announcement was made on September 10, 2026.

  • Cipla Partners with Qilu to License Keytruda Biosimilar in US
    8 September 2026
    Cipla Partners with Qilu to License Keytruda Biosimilar in US
    Invagen Pharmaceuticals Inc, a wholly owned subsidiary of Cipla Limited announced that it has entered into a strategic partnership with Qilu Pharmaceutical Co., Ltd. (hereinafter referred to as Qilu), for the exclusive licensing and supply of QL2107, a biosimilar to Keytruda® (pembrolizumab), for the United States
  • American Regent Recalls Three Lots of Epinephrine Injection Over Particulate Matter and Sterility Concerns
    5 September 2026
    American Regent Recalls Three Lots of Epinephrine Injection Over Particulate Matter and Sterility Concerns

    American Regent, Inc. has announced a voluntary nationwide recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multiple-dose vials in the United States. The recall, announced on September 3, 2026, was initiated after complaints involving leaking and cracked vials raised concerns about the sterility of the affected products.

  • FDA Raises Fresh Safety Concerns Over Unapproved GLP-1 Weight-Loss Drugs
    3 September 2026
    FDA Raises Fresh Safety Concerns Over Unapproved GLP-1 Weight-Loss Drugs

    The U.S. Food and Drug Administration (FDA) has issued a detailed warning about the risks associated with unapproved and compounded GLP-1 drugs being used for weight loss, highlighting concerns related to product quality, dosing errors, counterfeit medicines and improper storage.

  • Gland Pharma’s Visakhapatnam Facilities Clear USFDA Inspection With Zero Observations
    3 September 2026
    Gland Pharma’s Visakhapatnam Facilities Clear USFDA Inspection With Zero Observations

    Gland Pharma Limited has announced the successful conclusion of a routine Good Manufacturing Practice (GMP) inspection conducted by the United States Food and Drug Administration (USFDA) at its facilities in Visakhapatnam.

    The inspection was carried out at the company’s VSEZ Sterile Oncology Formulations Facility and API Facility in Visakhapatnam. The regulatory inspection commenced on August 24, 2026, and concluded on September 1, 2026.

  • ARPA-H Backs 125 Million USD Drive to Enable On-Demand Manufacturing of Personalized RNA Medicines
    3 September 2026
    ARPA-H Backs 125 Million USD Drive to Enable On-Demand Manufacturing of Personalized RNA Medicines

    The Advanced Research Projects Agency for Health (ARPA-H) has selected five research teams to develop new technologies aimed at making individualized, RNA-based genetic medicines faster and more accessible.

    The initiative is part of ARPA-H’s Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program, which could receive up to 125 million USD in research and development funding. The program seeks to establish an automated, distributed manufacturing network capable of producing genetic medicines on demand and closer to the point of care.

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