Regulation

Imfinzi approved in the EU for the treatment of extensive-stage small cell lung cancer

AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.

FDA approves Onureg as continued treatment for adults in first remission with AML

Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has approved Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy and who are not able to complete intensive curative therapy.

Omeros’ investigational new drug application for OMS906 cleared by FDA

Omeros Corporation today announced that its Investigational New Drug Application (IND) to begin clinical trials with OMS906 has been cleared by the U.S. Food and Drug Administration (FDA).

Gilead gets FDA EUA status for Veklury to also treat patients with moderate Covid-19

Gilead Sciences has secured expanded emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its investigational antiviral Veklury (remdesivir) to treat not only hospitalised patients suffering from severe COVID-19, but also those who were moderately afflicted.

Rocket Pharmaceuticals receives FDA fast track designation for RP-L401 gene therapy for infantile malignant osteopetrosis

Rocket Pharmaceuticals, a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to RP-L401, the Company’s lentiviral vector (LVV)-based gene therapy for the treatment of Infantile Malignant Osteopetrosis (IMO), a rare, severe monogenic bone resorption disorder characterized by skeletal deformities, neurologic abnormalities and bone marrow failure.

HiFiBiO submits IND application for SARS-CoV-2 neutralising antibody to treat Covid-19 patients

HiFiBiO Therapeutics, a multinational biotherapeutics company focused on the development of novel antibodies for immunomodulation, announced today the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for a novel SARS-CoV-2 neutralizing antibody for the treatment of Covid-19 patients.

GSK gets EC nod for BLENREP to treat relapsed and refractory multiple myeloma

GlaxoSmithKline (GSK) has secured conditional marketing authorisation from the European Commission (EC) for its BLENREP (belantamab mafodotin) to treat patients with relapsed and refractory multiple myeloma.

Exelixis announces submission of sNDA to FDA for CABOMETYX plus Opdivo for advanced RCC

Exelixis announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX (cabozantinib) in combination with Opdivo® (nivolumab) for patients with advanced renal cell carcinoma (RCC).

FDA issues EUA for convalescent plasma as potential promising Covid–19 treatment

The US Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.