Shilpa Biologicals and partner mAbTree Biologics AG secured FDA Orphan Drug Designation for a novel monoclonal antibody targeting Essential Thrombocythemia and Polycythemia Vera, marking a key step toward new treatments for rare blood cancers.
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India’s drug regulator has barred pharmaceutical companies from promoting weight-loss drugs, warning against direct and surrogate advertising.
The Ministry of Health and Family Welfare (MoHFW) has published a draft Gazette notification proposing an amendment to the Drugs Rules, 1945, to make changes to the requirements of testing of blood products.
AbbVie reported encouraging Phase 1 results for its experimental obesity therapy ABBV-295, showing meaningful weight loss and a favorable safety profile in adults during a 12–13 week clinical study.
Lupin Ltd's Ankleshwar plant receives two observations from the U.S. FDA after inspection. The company promises to address the issues while adhering to CGMP standards for quality and safety.
Sun Pharmaceutical has announced the acquisition of US oncology company Checkpoint Therapeutics for $355 million, including FDA-approved skin cancer drug UNLOXCYT, strengthening its global cancer treatment portfolio.
India’s pharmaceutical industry may face export disruptions worth up to Rs 5,000 crore as escalating conflict in West Asia affects shipping routes, raises freight costs, and threatens supply chains for medicines and raw materials.
The FDA has approved Ascendis Pharma’s Yuviwel, a once-weekly treatment for children with achondroplasia. The new therapy offers an alternative to daily injections and showed strong growth results in clinical trials.
The World Health Organization has unveiled critical updates to the influenza vaccine for the 2026-2027 northern hemisphere season, fully refreshing all strains to counter the rapid spread of the new A(H3N2) subclade K variant and...
CDSCO now allows companies to begin lab testing of new drugs immediately after filing applications. The move aims to speed approvals for manufacturing or importing drugs while keeping technical scrutiny for later stages.
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