India is exploring options to enhance the World Health Organisation (WHO) global benchmarking standards for medicines, aimed at standardizing and reinforcing the drug regulatory system for the safety, quality, and effectiveness of medications
Bayer’s investigational MRI contrast agent gadoquatrane is drawing industry attention today after new pediatric data strengthened its safety and performance profile. The company revealed fresh results from its QUANTI Pediatric study at the RSNA...
Biocon Limited has unveiled a major shift. It confirmed plans to fully integrate Biocon Biologics as a wholly owned subsidiary once regulatory and shareholder approvals are cleared. The move marks a pivotal moment for the company as it prepares...
Merck Animal Health, referred to as MSD Animal Health outside the U.S. and Canada, a branch of Merck & Co., Inc., Rahway, New Jersey, USA, revealed that the US Food and Drug Administration (FDA) has provided conditional approval for Exzolt Cattle-CA1
Drug-maker Lupin said on December 5, 2025, that it has received tentative approval from the US Food and Drug Administration (USFDA) for its generic version of Siponimod Tablets. The approved strengths are 0.25 mg, 1 mg, and 2 mg. These tablets...
The Establishment Inspection Report (EIR) issued to Zydus Lifesciences by the U.S. Food and Drug Administration (USFDA) concerning the GMP follow-up inspection at its injectable manufacturing facility in Jarod, Vadodara. This audit was carried out be
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Granules India reported that its subsidiary in the U.S., with step-down operations, Granules Consumer Health, LLC, has passed a Good Manufacturing Practice (GMP) inspection conducted by the U.S. Food and Drug Administration (FDA) with zero observatio
Sanofi has completed the acquisition of Vicebio Ltd, and this will make it stronger in the vaccine portfolio and prove its role as an innovative biopharma leader. The acquisition combines an exciting early-stage combination vaccine against...
Astrazeneca's presence at the 2025 ASH Annual Meeting is the largest sharpe in the history of ASH and represents Astrazeneca's continuing efforts to lead the way in haematology. The company's 65 abstracts represent an impressive milestone across...
Global pharma leader Lupin has taken a major step forward in the U.S. biosimilar market with a new exclusive licensing agreement for Armlupeg (pegfilgrastim-unne). The company announced today that it has partnered with Valorum Biologics, a...
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