Gilead Sciences has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for its investigational antiviral Veklury (remdesivir) seeking its approval for the treatment of Covid-19.
11 Aug 2020
04 Aug 2020
Calidi Biotherapeutics said that the Investigational New Drug (IND) application submitted by its partner, Personalized Stem Cells, Inc. (PSC), has received FDA approval for the treatment of COVID-19 and pneumonia patients using stem cell therapy.
31 Jul 2020
AstraZeneca’s TAGRISSO (osimertinib) has been granted Breakthrough Therapy Designation (BTD) in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent.
30 Jul 2020
Merck announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate in Merck’s oncology pipeline, for the treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required.
27 Jul 2020
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for IMBRUVICA (ibrutinib) to include the combination with rituximab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
22 Jul 2020
Aurinia announces FDA acceptance of NDA filing and priority review for voclosporin to treat lupus nephritis
Aurinia Pharmaceuticals, a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for voclosporin, as a potential treatment for lupus nephritis (LN), a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus (SLE).
09 Jul 2020
Concert Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the Company’s oral Janus kinase inhibitor, CTP-543, for the treatment of adult patients with moderate-to-severe alopecia areata.
06 Jul 2020
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate (ADC), for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.
26 Jun 2020
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.
15 Jun 2020
For the outstanding efficiency and scalability, high-performance liquid chromatography (HPLC) has been widely used for purification of high-quality APIs and intermediates in the pharmaceutical industry.