Pharma News

The U.S. Food and Drug Administration (FDA) has approved Trutakna (atacicept-vymj) to reduce proteinuria (excess protein in the urine) in adults with primary Immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The approval provides a new treatment option for patients with this rare kidney disease, which can eventually lead to kidney failure.

Researchers have identified critical antibody binding sites on the JC polyomavirus (JCPyV), a breakthrough that could pave the way for the first effective treatments and vaccines against the virus responsible for progressive multifocal leukoencephalopathy (PML), a rare but usually fatal brain disease affecting people with severely weakened immune systems. The findings were published in the journal PNAS.

Researchers have uncovered a key biological mechanism that explains why muscles become weaker with age and why regular exercise remains one of the most effective ways to preserve muscle strength. The findings identify a gene called DEAF1 as a major driver of age-related muscle decline and suggest it could become a promising target for future therapies.

Vertex Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of CASGEVY (exagamglogene autotemcel), allowing its use in children 2 years of age and older with sickle cell disease (SCD) experiencing recurrent vaso-occlusive crises (VOCs) and transfusion-dependent beta thalassemia (TDT). The therapy was previously approved only for patients aged 12 years and older.

Glenmark Pharmaceuticals Inc., USA, a wholly owned subsidiary of Glenmark Pharmaceuticals Limited, has announced the launch of Olanzapine for Injection, 10 mg/vial, Single-Dose Vial in the United States. The newly launched product is bioequivalent and therapeutically equivalent to Zyprexa® IntraMuscular Injection 10 mg/vial (NDA 021253) marketed by Cheplapharm Registration GmbH.

A new scientific review has highlighted the growing potential of liquid biomarkers to transform the early detection, diagnosis, and treatment monitoring of colorectal cancer (CRC), offering a less invasive alternative to traditional screening methods such as colonoscopy.

In a significant move to strengthen the regulation of advanced biological therapies in India, the Ministry of Health and Family Welfare has notified the Drugs (Eighth Amendment) Rules, 2026, expanding the scope of the Central Licence Approving Authority (CLAA) under the Drugs Rules, 1945. Through this amendment, Cell or Stem Cell Derived Products, Gene Therapeutic Products, and Xenografts have been formally included alongside Recombinant DNA (r-DNA) derived drugs within the CLAA licensing framework.

Mankind Pharma has announced a strategic collaboration with Denovo Sciences to strengthen its drug discovery capabilities through artificial intelligence (AI), marking a significant step toward technology-enabled pharmaceutical research. The partnership aims to accelerate the identification of promising drug candidates while reducing the time and cost associated with early-stage drug development.