Pfizer has secured approval from the European Commission (EC) for its Daurismo (glasdegib) to treat certain adult patients with newly diagnosed acute myeloid leukaemia (AML).
GlaxoSmithKline (GSK) has secured approval in Japan for Duvroq (daprodustat) tablets for the treatment of anaemia caused by chronic kidney disease (CKD).
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
Roche has secured approval from the US Food and Drug Administration (FDA) for its Phesgo to treat early and metastatic HER2-positive breast cancer.
Bristol Myers Squibb and Acceleron Pharma announced that the European Commission (EC) has approved Reblozyl (luspatercept) for the treatment of:
Aadi Bioscience announced that the company has initiated submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the treatment of advanced (metastatic or locally advanced) malignant PEComa (perivascular epithelioid-cell tumor) – a rare form of sarcoma driven by mTOR activation for which there is currently no approved therapy.
NeuroRx and Relief Therapeutics have secured fast track designation from the US Food and Drug Administration (FDA) to evaluate RLF-100 (Aviptadil) to treat acute lung injury/acute respiratory distress syndrome associated with Covid-19.
Deciphera Pharmaceuticals announced that Health Canada has authorized QINLOCK (ripretinib), a switch-control tyrosine kinase inhibitor, for sale in Canada for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with imatinib, sunitinib, and regorafenib.
Indian drugmaker Cipla has introduced the generic version of remdesivir, dubbed Cipremi, to treat patients with severe Covid-19 disease.
The Indian Central Drugs Standard Control Organisation (CDSCO) has approved the use of Glenmark Pharmaceuticals' generic for Favipiravir and Cipla and Hetero Drugs' respective generics for Remdesivir for the treatment of Covid-19 patients.
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