AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted priority review for the MEK 1/2 inhibitor selumetinib as a potential new medicine for pediatric patients aged three years and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs)
15 Nov 2019
11 Nov 2019
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMBRUVICA (ibrutinib) in combination with rituximab for the first-line treatment of younger patients (70 years old or younger) with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
08 Nov 2019
Johnson & Johnson announced that Janssen Pharmaceutical Companies is seeking approval from the European Medicines Agency (EMA) for an investigational Ebola vaccine regimen.
31 Oct 2019
Roche’s marketing applications for satralizumab in neuromyelitis optica spectrum disorder accepted for review by EMA and FDA
Roche announced that the European Medicines Agency (EMA) has validated the company’s Marketing Authorisation Application (MAA) for satralizumab for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD), granting it Accelerated Assessment.
25 Oct 2019
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with a primary focus in hematology and oncology, announced today that the company submitted an updated Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ROLONTIS (eflapegrastim).
18 Oct 2019
Trastuzumab deruxtecan granted FDA priority review to treat patients with HER2-positive metastatic breast cancer
AstraZeneca and Daiichi Sankyo announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted priority review.
07 Oct 2019
DBV Technologies, a clinical-stage biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for its investigational Viaskin Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years.
03 Oct 2019
GlaxoSmithKline (GSK) and Innoviva have filed an application for their respiratory drug Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) in the US seeking its use for the treatment of asthma in adults.
23 Sep 2019
EMD Serono, the biopharmaceutical business of Merck, and Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
17 Sep 2019
AstraZeneca’s Farxiga (dapagliflozin) has been granted fast track designation from the US Food and Drug Administration (FDA) for its use in reducing the risk of heart failure.