Alembic Pharmaceuticals has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bosutinib Tablets.

Vadodara: Alembic Pharmaceuticals Limited has announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) ...

29 May 2025 Artificial Intelligence (AI) has rapidly evolved from a promising technology to a core enabler of innovation in the pharmaceutical industry. Today, AI is estimated to generate between $350 ...

Credit: JOURNEY STUDIO7/Shutterstock. Daiichi Sankyo and MSD have voluntarily withdrawn the biologics licence application (BLA) in the US for their HER3-directed DXd antibody drug conjugate (ADC) ...

The companies said that their decision to pull the Biologics License Application (BLA) follows a topline readout from a Phase 3 trial for HER3-DXd and discussions with the FDA. It was not related ...

especially those provisions that provide for a 30-month postponement of FDA approval of a generic's Abbreviated New Drug Application ("ANDA"), to allow the patent issues to be resolved in court ...

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and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sibeprenlimab, an ...

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