U.S. drugmaker Merck & Co. Inc. said on March 6 the experimental antiviral drug molnupiravir the company is developing with Ridgeback Bio showed a quicker reduction in infectious virus in its phase 2a study among participants with early Covid-19.
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FDA Approves First Biologic for SSc-ILD
Adults, Approvals, Autoimmune Diseases, Biologics, Blockbusters, Clinical Trials, FDA, Genentech, Immune System, New Indications, Pulmonary Function, R&D, Rheumatoid Arthritis, Scleroderma, Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD), Therapeutics, VentilatorsThe U.S. Food and Drug Administration approved Genentech’s Actemra (tocilizumab) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
The gout medication colchicine will be tested in a large UK study looking into potential early-stage Covid-19 treatments and enrollment criteria was widened for the latest arm of the trial, University of Oxford researchers said on March 3.
Merck announced on March 1 the voluntary withdrawal of the U.S. indication for Keytruda (pembrolizumab) for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
FDA Approves Oncopeptides’ Pepaxto for Triple-Class Refractory Multiple Myeloma
Approvals, Brands, Clinical Trials, Dexamethasone, FDA, Human Anti-CD38 Monoclonal Antibody, Immunomodulatory Agents, Product Launches, Proteasome Inhibitors, R&D, Steroids, Therapeutics, Triple-Class Refractory Multiple MyelomaThe U.S. Food and Drug Administration approved Oncopeptides AB’s Pepaxto (melphalan flufenamide) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
The U.S. Food and Drug Administration approved AbbVie’s biologic therapy Humira (adalimumab) as a treatment for moderate-to-severe active ulcerative colitis in children aged 5 years and older.
Bristol Myers Squibb announced plans for a new manufacturing plant in Devens, Mass., adding to the company’s cell therapy network.
Regeneron and Sanofi Collaboration Receives Third FDA Drug Approval
Advanced Non-Small Cell Lung Cancer, Approvals, Blockbusters, Chemoradiation, Clinical Trials, FDA, Hedgehog Pathway Inhibitors, Monoclonal Antibodies, New Indications, PD-1/PD-L1 inhibitors, Progression-Free Survival (PFS), R&D, Regeneron Pharmaceuticals, Sanofi, Therapeutics, TumorsRegeneron and Sanofi’s checkpoint inhibitor Libtayo (cemiplimab-rwlc) won U.S. Food and Drug Administration approval for the first-line treatment of patients with advanced non-small cell lung cancer whose tumors have high PD-L1 expression.
AstraZeneca will voluntarily withdraw the use of the company’s Imfinzi to treat advanced bladder cancer in the United States after the cancer drug failed to meet post-approval requirements, the Anglo-Swedish drugmaker said.
Entresto granted expanded indication in chronic heart failure by FDA
Blockbusters, Chronic Heart Failure, Expanded Indication, FDA, Heart Failure with Preserved Ejection Fraction (HFpEF), Heart Failure with Reduced Ejection Fraction (HFrEF), Label Expansion, Left Ventricular Ejection Fraction (LVEF), Novartis, TherapeuticsNovartis’ Entresto is the first therapy approved in the United States to treat patients diagnosed with guideline-defined heart failure to include both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF).