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  • 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
  • India, China and Pakistan Named in US 2027 Major Drug Transit and Production List
    India, China and Pakistan Named in US 2027 Major Drug Transit and Production List

    The United States has included India, China and Pakistan among 23 countries designated as major drug transit or major illicit drug-producing countries for fiscal year 2027. The designation was submitted to the U.S. Congress on September 15, 2026, as part of the annual U.S. “Major’s List,” which identifies countries considered significant sources or transit points for illicit drugs entering the United States.

  • Dr. Reddy’s Expands Lenacapavir Partnership With Gilead for Future HIV Prevention Access
    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.

  • Vera Therapeutics Reports Sustained Kidney Function in Phase 3 Trial of TRUTAKNA for IgA Nephropathy
    Vera Therapeutics Reports Sustained Kidney Function in Phase 3 Trial of TRUTAKNA for IgA Nephropathy

    Vera Therapeutics has announced final efficacy results from the Phase 3 ORIGIN 3 study of TRUTAKNA™ (atacicept-vymj), reporting sustained stabilization of kidney function and a reduced risk of kidney disease progression in adults with primary IgA nephropathy (IgAN). The final analysis included 428 patients with primary IgAN who were considered at risk of disease progression.

  • Sanofi to Transfer 20 Mature Medicines and 3 Manufacturing Sites to Cheplapharm in Strategic Partnership
    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.

  • FDA Launches Expedited IND Pilot to Speed First-in-Human Clinical Trials
    FDA Launches Expedited IND Pilot to Speed First-in-Human Clinical Trials

    The U.S. Food and Drug Administration (FDA) has launched a new Expedited Investigational New Drug (IND) Pilot Program aimed at reducing the time required to move promising drug candidates from development into first-in-human (FIH) clinical trials in the United States.

    Under the pilot, drug sponsors will partner with Qualified Research Institutions (QRIs), which can include academic medical centers, contract research organizations, health networks and other research organizations with relevant scientific and regulatory expertise.

  • MBU Hosts National Conference on Integrating AYUSH with Community Medicine, Advancing Holistic Healthcare
    MBU Hosts National Conference on Integrating AYUSH with Community Medicine, Advancing Holistic Healthcare

    Mohan Babu University (MBU) successfully hosted the two-day National Conference on Integrating AYUSH with Community Medicine (IACMI-2026), sponsored by the Indian Council of Social Science Research (ICSSR).

  • GSK’s Shingrix Prefilled Syringe Approved in Japan for Shingles Prevention
    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.

  • Alembic Pharma Completes USFDA Inspection Without Form 483 Observations
    Alembic Pharma Completes USFDA Inspection Without Form 483 Observations
    Alembic Pharmaceuticals Limited has successfully completed an unannounced onsite inspection conducted by the United States Food and Drug Administration (USFDA) at its Bioequivalence Facility in Vadodara, Gujarat.
  • Scientists Uncover New Inherited Eye Disorder Where Night-Vision Loss Comes Before Retinal Damage
    Scientists Uncover New Inherited Eye Disorder Where Night-Vision Loss Comes Before Retinal Damage
    An international team of researchers has identified a previously unrecognized inherited retinal disorder linked to a rare variant in the EFEMP1 gene. The newly characterized condition primarily affects the peripheral retina and rod photoreceptors involved in vision under low-light conditions, while central vision can remain relatively preserved for many years.
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