Skip to main content
  • 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.

    admin Fri, 06/04/2021 - 15:23
  • 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.

    admin Tue, 05/25/2021 - 15:53
  • 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.

  • FDA Approves Treatment for Chronic Kidney Disease

    The U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression. 

  • Zydus Cadila receives final approval from USFDA for Propafenone Hydrochloride Extended-Release Capsules

    Zydus Cadila has received final approval from the USFDA to market Propafenone Hydrochloride Extended- Release Capsules USP, 225 mg, 325 mg, and 425 mg (US RLD: Rythmol Capsules). Propafenone is known as an anti-arrhythmic drug. It works by blocking the activity of certain electrical signals in the heart that can cause an irregular heartbeat.

  • FDA Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy

    The U.S. Food and Drug Administration has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy in certain patients. The Hominis Surgical System is intended for benign hysterectomy (removal of the uterus for non-cancerous conditions) with salpingo-oophorectomy (removal of one or both fallopian tubes and ovaries).

  • Johnson and Johnson Covid-19 Vaccine receives FDA Nod for Emergency Use

    Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.

Subscribe to USFDA

Search this website