upcoming fda approvals

January 21, 2021. 2020 was a peculiar year for drug approvals, partly because the ongoing COVID-19 pandemic delayed many clinical trials. Date of Approval: February 3, 2021Treatment for: Non-Small Cell Lung Cancer. Category: Events. Date of Approval: December 16, 2020Treatment for: Breast Cancer. The PDUFA/FDA Approval Calendar and Finding Potential FDA Approval Catalyst Dates. Date of Approval: February 26, 2021Treatment for: Multiple Myeloma. New Drug Approvals. Share Article. CDER highlights key Web sites. Thu Apr 1, 2021 Virtual Event: Allied Professionals Event. EvaluatePharma projects it will have 2026 annual sales of $1.8 billion. The serology test uses a single drop of fingertip blood to detect IgG antibodies to the virus in 15 minutes in point-of-care settings, meaning it does not require any offsite lab work. Gilead’s Veklury (Remdesivir) for COVID-19. It is the only approved spingosine-1-phosphate (S1P) receptor modulators for RMS patients with no genetic test and no label-based first-dose observation required for patients. Thu Mar 4, 2021 San Antonio Breast Cancer Conference Update 2021. Company: ViiV Healthcare Trodelvy binds to Trop-2 and delivers SN-38, an anti-cancer drug. Advancing Health through Innovation: New Drug Approvals 2020 (PDF 2MB) Text Version. Company: Durect Corporation Evaluate Pharma has projected estimated 2024 sales of $897 million. Pepaxto (melphalan flufenamide) is an anticancer peptide-drug conjugate indicated for use in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma. It is the first drug approved for thyroid eye disease. This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those … March 01, 2021 08:30 ET | … Thu Dec 3, 2020 WEBCAST: LYNPARZA as Maintenance Monotherapy or Combination Therapy in Advanced Ovarian Cancer. In them, the drug provided an average of 18% placebo corrected LDL-C lowering when used with moderate or high intensity statins. Our enhanced FDA calendar integrates PDUFA dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers all companies facing upcoming PDUFA dates. FDA Approvals; Industry News; Upcoming Events. FDA Approved: Yes (First approved July 15, 2019) Brand name: AirDuo Digihaler Generic name: fluticasone propionate and salmeterol Dosage form: Inhalation Powder Company: Teva Pharmaceuticals USA, Inc. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Novel Drug Approvals for 2020. antagonist indicated for the treatment of adult patients with advanced On February 28, the FDA approved Biohaven Pharmaceutical’s Nurtec ODT (Rimegepant) for the acute treatment of migraine in adults. Biotech stocks with key binary events/catalysts - FDA Approval/PDUFA dates, Advisory Committee and Phase 2 & 3 trial data releases dates are noted. All supporting data can be copied to the clipboard or downloaded as a CSV file. The FDA approved Novartis’ Kesimpta (ofatumumab), the first and only self-administered, targeted B-celll therapy for patients with relapsing multiple sclerosis (RMS) in August 20. The drug is an antibody-drug conjugate (ADC) directed against Trop-2, a cell-surface protein found on many solid cancers. At the beginning of 2020, nobody knew how bad COVID-19 would be or that Gilead Sciences’ remdesivir, which had failed to work in Ebola, would turn out to be the first drug granted Emergency Use Authorization (EUA) for COVID-19 in spring 2020 and then full approval on October 22, 2020. New … Category: Events. It is administered daily at home in liquid form by mouth or feeding tube. Category: Events. Novel FDA approvals and their outsourcing rise in the shadow of the pandemic. Up to date information on the latest FDA drug approvals. ACIP emergency meeting scheduled for 1 December with vote likely on distribution priority for health care personnel. Riabni (rituximab-arrx) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA). It was the first FDA-approved product for the company. The drug was approved under Priority Review, Fast Track and Breakthrough Therapy Designation, as well as Orphan Drug designation. It is more frequently diagnosed in younger and premenopausal women and is highly prevalent in African Americans and Hispanic women. FDA Approvals; Upcoming Events. Company: Merck Announcements. Drugmakers are pushing the FDA to resume inspections halted by the pandemic after the agency has deferred or denied drug approvals because it … The approval was supported by a global pivotal Phase III LDL-C lowering program run in more than 3,000 patients. In August, Nestlé acquired Aimmune for $2.6 billion, and became the point pharmaceutical business for Nestlé Health Science. TNBC is an aggressive form of breast cancer, making up to 20% of all breast cancers. Investing in biotechnology and pharmaceutical companies often comes with concerns of dilution and raises in order to continue to fund operations. The Institute for Clinical and Economic Review’s own estimate had been $2,800 as a fair price and said Gilead’s price was a “responsible pricing decision.” But that was based on if the drug ultimately demonstrated it significantly decreased death rates, which has not happened. Estimated sales for 2024 are $1.28 billion. As I have reiterated before, the best way to trade bio-pharmas are on upcoming catalysts. Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. Company: EMD Serono, Inc. FDA approves targeted treatment for rare Duchenne muscular dystrophy mutation. Company: Bristol-Myers Squibb Company View FDA Calendar. Eli Lilly’s Bamlanivimab for COVID-19 and Regeneron’s REGN-COV2. Innovation drives progress. The BioPharmCatalyst Biotech Earnings Calendar … Date of Approval: December 17, 2020Treatment for: non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Wegener's Granulomatosis, Microscopic Polyangiitis. Ebanga (ansuvimab-zykl) is a monoclonal antibody for the treatment of Zaire ebolavirus (Ebolavirus) infection in adults and children. Date of Approval: February 25, 2021Treatment for: Duchenne Muscular Dystrophy. Of the patient receiving Tepezza, 71% in Study 1 and 83% in Study 2 demonstrated a greater than 2-millimeter reduction in eye protrusion compared to 20$ and 10% in the placebo groups, respectively. Category: Events. Upcoming events; Medtech; Therapy Areas; About. SVB Leerink projects peak sales of about $1.3 billion for Regeneron, probably in 2021, with sales falling every year after that. Date of Approval: January 22, 2021Treatment for: Lupus Nephritis. Maya Sasson - April 19, 2020, 7:01 AM EDT. Roche’s Evrysdi (risdiplam) was approved on August 10 by the FDA for spinal muscular atrophy (SMA) in adults and children two months of age and older. Another strong year for novel drug approvals is in the making. Includes list of most recent approvals, the conditions approved for, and the approval history. Biotech Earnings Calendar. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Ofatumumab was first approved by the FDA in 2009 for chronic lymphocytic leukemia (CLL) as an intravenous infusion. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox. Date of Approval: February 12, 2021Treatment for: Small Cell Lung Cancer Myelopreservation Therapy.

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