• Zydus Cadila receives tentative approval from the USFDA for Ibrutinib Tablets

    Zydus Cadila has received tentative approval from the USFDA to market Ibrutinib Tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg. Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia.

  • FDA granted Breakthrough Therapy designation to pneumoniae vaccine

    Affinivax, Inc and Astellas Pharma Inc announced results from the Phase 2 clinical trial of ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae. Developed using Affinivaxs proprietary MAPS (Multiple Antigen-Presenting System) platform technology, ASP3772 is designed to offer both B-cell (antibody) and T-cell immune protection against Streptococcus pneumoniae. ASP3772 includes 24 pneumococcal polysaccharides, as well as two conserved pneumococcal proteins. The results from the Phase 2 clinical trial demonstrated that ASP3772 was well tolerated.

  • Tezepelumab Granted Priority Review By USFDA

    Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca.

  • FDA Approves Expanded Indication for Merck KEYTRUDA in Locally Advanced Cutaneous Squamous Cell Carcinoma

    Merck known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

  • NATCO receives approval for Carfilzomib Vials ANDA in the US market

    Natco Pharma Limited is pleased to announce that its marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received approval for its Abbreviated New Drug Application (ANDA) for Carfilzomib Vials ANDA (generic for KYPROLIS), from the U.S. Food and Drug Administration (USFDA).

  • FDA Grants Accelerated Approval for Alzheimer’s Drug

    The U.S. Food and Drug Administration approved Aduhelm for the treatment of Alzheimers, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.

  • Zydus Cadila receives tentative approval from USFDA for Osimertinib Tablets

    Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs nearly 25000 people worldwide and is dedicated to creating healthier communities globally.

  • Glenmark Pharmaceuticals receives ANDA approval for Icatibant Injection

    Glenmark Pharmaceuticals Limited has received final approval by the United States Food & Drug Administration (U.S. FDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, the generic version of Firazyr Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic Therapies, Inc. This marks Glenmark’s first synthetic decapeptide injectable approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina.

  • FDA grants priority review of maribavir for the treatment of post transplant with cytomegalovirus infection

    Takeda Pharmaceutical Company Limited announced that the U.S. Food & Drug Administration (FDA) has accepted a New Drug Application (NDA) for maribavir for the treatment of CMV infection in those that are refractory with or without resistance (R/R), in solid organ transplant (SOT) or hematopoietic cell transplant (HCT) recipients.

  • RYBREVANT got FDA Approval as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer

    The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration has granted the accelerated approval of RYBREVANTTM (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

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