The U.S. Food and Drug Administration granted accelerated approval of Gilead Sciences Inc.’s Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor.
The U.S. Food and Drug Administration approved a prefilled syringe for self-injection of the allergic diseases treatment Xolair developed by Novartis and Genentech, a Roche company.
Pfizer Inc. said on April 7 the U.S. Food and Drug Administration extended the review of the company’s experimental atopic dermatitis drug by three months, the latest regulatory setback for a class of treatments known as JAK inhibitors.
Shares of Supernus Pharmaceuticals climbed in trading on April 5 after the U.S. Food and Drug Administration’s April 2 approval of the company’s non-stimulant treatment for attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.
The U.S. Food and Drug Administration approved United Therapeutics Corporation’s Tyvaso (treprostinil) Inhalation Solution for the treatment of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.
FDA Issues CRL to Merck
Acquisitions, Agreements, Blockbusters, Business, Chemotherapy, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), FDA, Keytruda, Merck, Metastatic Urothelial Carcinoma (mUC), PD-1/PD-L1 inhibitors, Spin-offs, Therapeutics, Triple Negative Breast Cancer (TNBC)The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Merck for the company’s supplemental Biologics License Application for Keytruda (pembrolizumab) in high-risk early-stage triple-negative breast cancer.
The U.S. Food and Drug Administration accepted AbbVie’s New Drug Application for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist for the preventive treatment of migraine in adults who meet criteria for episodic migraine.
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U.S. FDA Approves Abecma for Relapsed or Refractory Multiple Myeloma
Approvals, B-cell maturation antigen (BCMA), Bristol Myers Squibb, CAR-T Therapy, Clinical Trials, Cytokine Release Syndrome (CRS), FDA/Regulatory, First-In-Class, Human Anti-CD38 Monoclonal Antibody, Immunomodulatory Agents, Proteasome Inhibitors, R&D, Relapse/Refractory Multiple Myeloma, TherapeuticsThe U.S. Food and Drug Administration approved Bristol Myers Squibb’s and bluebird bio’s Abecma (idecabtagene vicleucel) as the first anti-BCMA CAR T cell therapy for relapsed or refractory multiple myeloma.
AstraZeneca Defends Covid-19 Vaccine with Updated Data
AstraZeneca, Biomedical Advanced Research and Development Authority (BARDA), Coronavirus Disease 2019 (COVID-19), Covid-19 Data, COVID-19 Vaccines, Data Safety Monitoring Board (DSMB), Health Canada, Hospitalized COVID-19 Patients, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Oxford University, Symptomatic COVID-19 InfectionsAstraZeneca released primary analysis showing that the company’s AZD1222 vaccine demonstrated 76 percent efficacy against symptomatic Covid-19, 100 percent efficacy against severe or critical disease and hospitalizations, and 85 percent efficacy against symptomatic Covid-19 in people 65 years and older.