Experts have advised that it is urgently necessary to create a culture of quality in the pharmaceutical business in view of the sharp increase in US FDA inspections for compliance and quality assurance. They did this by highlighting the fall…
Tag: USFDA
The US Food and Drug Administration (FDA) has responded completely to Alvotech’s Biologics Licence Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira (adalimumab), according to a press release from the international biotech company Alvotech. The FDA’s reinspection of…
Indian healthcare providers see immense relevance to US FDA Orthopaedic Non-Spinal Bone Plates, Screws and Washers Premarket Notification (510(k)) Submissions Draft Guidance. This is going by the increasing number of orthopaedic surgeries requiring to embed this into the patient depending…
Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the generic version of Compazine®1 Tablets, 5 mg and 10 mg, of GlaxoSmithKline, have been given final approval by the United States Food & Drug Administration (U.S. FDA). Glenmark Pharmaceuticals Ltd….
Hutchmed (China) Limited reports that it has finished the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for fruquintinib, a highly potent and selective oral inhibitor of VEGFR-1, -2, and -3, for…
The US Food and Drug Administration has approved the company’s investigational new drug (IND) application for CABA-201, a fully human CD19-CAR T cell investigational therapy that contains the 4-1BB protein, according to Cabaletta Bio, Inc., a clinical-stage biotechnology company focused…
In order to treat persons with aortic regurgitation or stenosis, Abbott announced that the US Food and Drug Administration (FDA) has approved the company’s Epic Max stented tissue valve. With an enhanced design to further increase valve blood flow, this…
The first naloxone medication to be approved for use without a prescription is Narcan, a 4 milligramme (mg) naloxone hydrochloride nasal spray, according to the US Food and Drug Administration (FDA). The conventional treatment for opioid overdose is naloxone, a…
Tofersen, an investigational antisense drug for the treatment of people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis, was discussed at the Peripheral and Central Nervous System Drugs Advisory Committee meeting by the US Food and Drug Administration (FDA), according…
The US Food and Drug Administration (FDA) has designated NTLA-2002 for the treatment of hereditary angioedema as a Regenerative Medicine Advanced Treatment (RMAT), according to Intellia Therapeutics, Inc., a leading clinical-stage genome editing business (HAE). NTLA-2002 is a CRISPR-based in…
