Regulation

Oncternal gets FDA orphan drug designations for cirmtuzumab to treat MCL and CLL

Oncternal Therapeutics, a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, announced that the United States Food and Drug Administration (FDA) has granted the company orphan drug designations of cirmtuzumab for treatment of mantle cell lymphoma (MCL) and for treatment of chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL).

Pfizer gets EC approval for Daurismo to treat newly diagnosed acute myeloid leukaemia

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).

GSK’s Duvroq gets Japanese approval for anaemia caused by CKD

GlaxoSmithKline (GSK) has secured approval in Japan for Duvroq (daprodustat) tablets for the treatment of anaemia caused by chronic kidney disease (CKD).

FDA approves Merck’s KEYTRUDA for unresectable or metastatic MSI-H or dMMR colorectal cancer

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 gets FDA nod for Phesgo to treat HER2-positive breast 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.

EC approves Reblozyl for transfusion-dependent anemia in myelodysplastic syndromes or beta thalassemia

Bristol Myers Squibb and Acceleron Pharma announced that the European Commission (EC) has approved Reblozyl (luspatercept) for the treatment of:

Aadi Bioscience initiates rolling submission of NDA to FDA for nab-sirolimus for advanced malignant PEComa

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, Relief Therapeutics secure FDA fast track status for Covid-19 drug candidate

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 gets Canadian approval for QINLOCK for fourth-line gastrointestinal stromal tumour

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.