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When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. Reports. The .gov means it’s official.Federal government websites often end in .gov or .mil. Innovation drives progress. An official website of the United States government, : The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) Injection.

FDA Calendar 2. Find and follow all COVID-19 clinical trials. The public FDA Calendar is limited to 150 events in chronological order.

Only NASDAQ and NYSE stocks are covered. *The listed “FDA-approved use” on this website is for presentation purposes only. The .gov means it’s official.Federal government websites often end in .gov or .mil. Streamline your research and quickly compare the relative timing of competing catalysts. Date of Approval: October 14, 2020 Treatment for: Zaire Ebolavirus Infection Inmazeb is (atoltivimab, maftivimab, and odesivimab) is a monoclonal antibody combination indicated for the treatment of Zaire ebolavirus infection in adults and children, including newborns of mothers who … A regulatory event, for example a PDUFA date or Advisory Committee Meeting, will be issued with an exact date by the FDA. CDER Drug and Biologic Approvals for Calendar Year 2019; CDER Drug and Biologic Approvals for Calendar Year 2018; CDER Drug and Biologic Approvals for Calendar Year 2017 NOTE: LARGE CAP CATALYSTS - generally only Phase 3 catalysts noted in company presentations and/or earnings releases are shown. Exact dates for clinical data releases are only rarely issued. Biotech stocks with key binary events/catalysts - FDA Approval/PDUFA dates, Advisory Committee and Phase 2 & 3 trial data releases dates are noted. See. These calendars track upcoming PDUFA drug approval dates, FDA advisory committee meetings and Phase 2/3 trial data releases. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products, Recalls, Market Withdrawals and Safety Alerts, New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products, Center for Biologics Evaluation and Research, atoltivimab, maftivimab, and odesivimab-ebgn, To help detect certain types of neuroendocrine tumors, To treat neuromyelitis optica spectrum disorder, To treat Chagas disease in certain pediatric patients younger than age 18, To treat relapsed or refractory diffuse large B-cell lymphoma, To treat adult patients with myelodysplastic syndromes, To treat molecularly long-chain fatty acid oxidation disorders, To treat metastatic small cell lung cancer, Diagnostic agent for patients with Alzheimer’s disease, Diagnostic imaging agent for certain patients with breast cancer, To treat advanced gastrointestinal-stromal tumors, To treat patients with non small cell lung cancer, To treat patients with Parkinson’s disease experiencing “off” episodes, To treat adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease, To treat certain patients with cholangiocarcinoma, a rare form of cancer that forms in bile ducts, To treat advanced unresectable or metastatic HER2-positive breast cancer, To treat neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves, To treat relapsing forms of multiple sclerosis, To treat adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease, To help prevent nausea and vomiting after surgery, For the preventive treatment of migraine in adults, To treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C, To treat chronic idiopathic constipation (CIC) in adults, To treat adults with unresectable or metastatic gastrointestinal stromal tumor (GIST), Some of these products are innovative new products that never have been used in clinical practice. Streamline your research and quickly compare the relative timing of competing catalysts. However, most clinical release dates (i.e. Phase 1/2/3) are provided in a range format by companies (e.g, mid-2019 or 4Q 2019). View FDA Calendar The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. Sign up or log in to access our Enhanced FDA Calendar! This calendar tracks upcoming PDUFA drug approval dates and FDA advisory committee meetings. Inmazeb: atoltivimab, maftivimab, and odesivimab … NVS ( ) AIN457 (Cosentyx) Psoriatic arthritis.

Click to email this to a friend (Opens in new window), Click to share on Twitter (Opens in new window), Click to share on Facebook (Opens in new window), Click to share on Reddit (Opens in new window), Click to share on Tumblr (Opens in new window), Click to share on Pinterest (Opens in new window), Click to share on Pocket (Opens in new window), Click to share on LinkedIn (Opens in new window), Click to share on WhatsApp (Opens in new window), Click to share on Skype (Opens in new window), Click to share on Telegram (Opens in new window). Premium users - Refer to FDA Calendar Abbreviations in the FDA Calendar Glossary for terms used in the columns and other parts of the FDA Calendar. The .gov means it’s official.Federal government websites often end in .gov or .mil. by The Fold, Keep your ear to the ground with our FREE newsletter including our watch list, weekly review and daily updates. Phase 3: April 7-10, 2018 04/09/2018. The full calendar of approximately 800 events is available to PREMIUM MEMBERS which … For previous years' advisory committee calendars, see the FDA Archive. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts. Advisory Committee Meeting February 14-15, 2018 voted 4-6 against approval. FDA Calendar 3. Before sharing sensitive information, make sure you're on a federal government site. FDA Calendar information on all the BioTech Stocks and companies that are established and up and coming. The full calendar of approximately

Website design & development Before sharing sensitive information, make sure you're on a federal government site. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, CDER provides scientific and regulatory advice needed to bring new therapies to market. Phase 1 catalysts for small-cap companies only are listed. Biotech Stock Catalyst and FDA Calendar for your biotech stock investing. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Sorry, your blog cannot share posts by email. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development. FDA Calendar 4. Refer to the FDA Calendar Glossary for a list of terms used in the FDA Decision Calendar and the Biotech Historical Catalyst Calendar for completed biotech stock catalysts. Subscribe HERE to ensure you receive your weekly FREE copy of the BioPharmCatalyst Biotech Stock Watch list and/or our daily option of an end-of-day summary of the day's Biotech Stock Price Movers and Pipeline Database updates. The public FDA Calendar is limited to 150 events in chronological order. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. To treat HIVPress ReleaseDrug Trials Snapshot.


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