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Drug major Merck & Co. Inc. (MRK) announced Friday that KEYTRUDA plus chemotherapy met primary endpoint of progression-free survival or PFS as first-line therapy for advanced or recurrent Endometrial Carcinoma. Endometrial carcinoma begins in the inner lining of the uterus, which is known as the endometrium,...

Gracell Biotechnologies Inc. (GRCL) announced the FDA has cleared the company's Investigational New Drug application and the company can proceed to initiate a Phase 1b/2 clinical trial in the U.S. of GC012F for the treatment of relapsed/refractory multiple myeloma. The company plans to initiate a Phase...

gsk feb02 The U.S. Food and Drug Administration approved GlaxoSmithKline LLC's Jesduvroq tablets (daprodustat) for anemia caused by chronic kidney disease or CKD for adults who have been receiving dialysis for at least four months. It is the first oral treatment for anemia, i.e., decreased number of red blood cells, in the given indication that has received FDA approval.

Moderna, Inc. (MRNA) announced mRNA-1345 has been granted Breakthrough Therapy Designation by the FDA for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 years or older. The designation was based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy...

Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi announced the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for Dupixent, recommending expanded approval in the European Union to treat severe atopic dermatitis in children 6 months to 5 years old...

Drug major Merck & Co. Inc. (MRK) announced Friday that the U.S. Food and Drug Administration has approved its anti-PD-1 therapy KEYTRUDA as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a 4 centimeters), II, or...

Merck Animal Health, a division of Merck & Co., Inc. (MRK), announced the U.S. Food and Drug Administration's approval of an expanded indication for BRAVECTO Chews for Dogs. . The new indication treats and controls Asian longhorned ticks. Holger Lehmann, vice president, Pharmaceutical Research and...

Evotec AG (EVTCY.PK), a German drug maker, said on Thursday that it has signed a strategic partnership and license deal with Janssen Biotech, Inc., an arm of Johnson & Johnson (JNJ), to develop first-in-class targeted immune-based therapies for oncology. Evotec will work closely with Janssen during...

Cidara Therapeutics, Inc. (CDTX) and Melinta Therapeutics announced the FDA Antimicrobial Drugs Advisory Committee voted favorably 14 to 1 that Cidara, as part of its New Drug Application, provided sufficient evidence supporting a favorable benefit-risk assessment for a limited use indication for rezafungin...

Kura Oncology, Inc. (KURA) announced the clearance by the FDA of the Investigational New Drug application for KO-2806 for the treatment of advanced solid tumors. The company plans to evaluate safety, tolerability and preliminary antitumor activity of KO-2806 in a Phase 1 first-in-human study as a monotherapy...

BiondVax Pharmaceuticals Ltd. (BVXV) announced additional results in a preclinical proof-of-concept study of its inhaled NanoAb COVID-19 drug. COVID-19 illness was virtually prevented in hamsters administered inhaled NanoAb and infected three hours later with SARS-CoV-2. The company said the data from...

Blueprint Medicines Corporation (BPMC) announced the FDA has accepted the company's supplemental new drug application for AYVAKIT for the treatment of adults with indolent systemic mastocytosis. The FDA granted priority review with an action date of May 22, 2023 under the PDUFA. The regulatory application...

Jazz Pharmaceuticals plc (JAZZ) and Zymeworks Inc. (ZYME) announced tolerability and efficacy results, including the first overall survival data, from a Phase 2 trial examining zanidatamab in combination with chemotherapy, in first-line patients with HER2-expressing metastatic gastroesophageal adenocarcinoma....

Horizon Therapeutics plc (HZNP) announced that the primary endpoint was met for the second population in its Phase 2 clinical trial evaluating dazodalibep for the treatment of Sjgren's syndrome. The positive results in the first patient population were announced in September 2022. The second patient...

NeuroBo Pharmaceuticals, Inc. (NRBO) has appointed Joseph Hooker as Interim Chief Executive Officer and President. The Board plans to initiate a candidate search with the assistance of a leading executive search firm to identify Price's permanent successor. Previously, Hooker was Sr. Director of Clinical...

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