US Patients will now be able to access another biosimilar version of Trastuzumab with the FDA approval of Pfizer’s Trazimera in the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Data supplied with the application supported the similarity of Trazimera to its reference
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Regulatory Professionals is one of the fastest growing global integrated regulatory outsourcing providers with a network of 20,000 pharmaceutical professionals globally. Working exclusively within the regulatory functions of Pharmaceutical, Biotechnology, Medical Device, Consumer health / OTC and Diagnostics industries.
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MYR Pharma has gained Promising Innovative Medicine (PIM) status in the UK for Myrcludex, its first-in-class entry inhibitor for the treatment of chronic hepatitis delta (HDV) infections. Decision was made on the basis of the MHRA believing the drug to be a strong contender for the UK’s Early Access to Medicines Scheme (EAMS), which provides
Biogen & Alkermes announce that the U.S. FDA has accepted for review the New Drug Application (NDA) for diroximel fumarate in multiple sclerosis (MS). The drug, diroximel fumarate, is a novel oral fumarate in development for the treatment of relapsing forms of MS. The approval has a target action date in the fourth quarter of