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US Food and Drug Administration to Drop Two-Study Requirement for New Drug Approvals
The US Food and Drug Administration has announced plans to eliminate its long-standing expectation that new medicines be supported by at least two pivotal clinical trials, signaling a significant shift in regulatory policy aimed at accelerating patient access to innovative therapies.
Ingredients | 19/02/2026 | By Darshana
Janux Therapeutics has entered into a global collaboration and exclusive licensing agreement with Bristol Myers Squibb to develop a novel cancer therapy for solid tumours. The partnership is valued at up to USD eight hundred fifty million, including upfront payments and development, regulatory, and commercial milestones.
Ingredients | 23/01/2026 | By Darshana | 101
Organon to Market Bempedoic Acid Therapy Nilemdo in Key European Markets
Organon, a global healthcare company focused on delivering impactful medicines and solutions for everyday health, has entered into an agreement with Daiichi Sankyo Europe to commercialize Nilemdo (bempedoic acid) across France, Denmark, Iceland, Sweden, Finland, and Norway.
Ingredients | 11/01/2026 | By Darshana | 205
Co-Diagnostics Inc, a molecular diagnostics company with a patented platform for developing molecular diagnostic tests, has received an Australian patent grant for its next-generation polymerase chain reaction (PCR) platform, reinforcing its intellectual property base supporting future manufacturing and commercialization.
Ingredients | 31/12/2025 | By Darshana
Boehringer Advances First-in-Class Triple-Agonist Peptide for Obesity and CRM Disorders
Boehringer Ingelheim has announced the advancement of BI 3034701, a long-acting, potential first-in-class triple-agonist peptide being developed for the treatment of obesity. The progress marks a key milestone in the company’s strategy to tackle the global burden of obesity and its interlinked cardiovascular, renal, and metabolic (CRM) complications.
Ingredients | 09/12/2025 | By Darshana | 205
Citius Oncology Launches Lymphir, a Novel FDA-Approved Therapy for Relapsed or Refractory CTCL
According to Leonard Mazur, chairman and CEO of Citius Oncology and Citius Pharmaceuticals, the launch of Lymphir marks a major milestone for the company. He highlighted its median time to response of 1.4 months, noting that the therapy may provide rapid relief from the severe and debilitating itching associated with CTCL.
Ingredients | 04/12/2025 | By Darshana | 119
Zaynich milestone: First Indian-developed NCE accepted by US FDA
Wockhardt Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its novel, first-in-class antibiotic Zaynich.
Ingredients | 02/12/2025 | By Darshana | 275
Eisai completes FDA submission for weekly subcutaneous LEQEMBI autoinjector
Eisai has completed the rolling submission of its Supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for LEQEMBI IQLIK, a once-weekly subcutaneous autoinjector formulation of lecanemab-irmb (LEQEMBI), following the FDA’s Fast Track designation.
Ingredients | 27/11/2025 | By Darshana | 122
Lupin Manufacturing Solutions Commissions Dedicated Oncology Block at Vizag Facility
Lupin Manufacturing Solutions (LMS), a wholly owned subsidiary of global pharma major Lupin, has commissioned a dedicated oncology manufacturing block at its Vizag facility in India.
Ingredients | 12/11/2025 | By Dineshwori | 233
Valiant Advanced Sciences Begins Commercial Operations at New Greenfield Facility in Gujarat
According to Valiant Advanced Sciences, the new plant is dedicated to the production of Acetic Anhydride, a key chemical in the Ketene and Diketene derivatives category, serving both domestic and international markets.
Ingredients | 07/11/2025 | By Dineshwori | 221
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