Gavreto (pralsetinib) is an oral selective RET kinase inhibitor for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion- positive non-small cell lung cancer (NSCLC) as detected by an FDA approved … The FDA's call on whether to approve Biogen's experimental Alzheimer's drug, aducanumab, will be the "most important decision" it will make in 2020, Bernstein analyst Ronny Gal says. 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, To treat patients with hereditary angioedema, For detection and localization of prostate cancer, To treat high-risk refractory or relapsed neuroblastoma, To treat obesity and the control of hunger associated with pro-opiomelanocortin deficiency, a rare disorder that causes severe obesity that begins at an early age, 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. In late November—at least 3 months earlier than expected— the FDA approved a drug to treat sickle cell disease. Phase 3 data released July 25, 2017. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. 2020 Biological Approvals The Center for Biologics Evaluation and Research (CBER) regulates products under a variety of regulatory authorities. Date of Approval: September 4, 2020 Treatment for: Non-Small Cell Lung Cancer. Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application. The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. On October 30, 2019, the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) met to discuss the benefits and risks of Twirla and voted 14 to 1, with one abstention, that the benefits of Twirla (AG200-15) in the prevention of pregnancy outweigh the risks to support approval. 04/29/2021. See also: New Drug Approvals, New Drug Applications, Generic Drugs. First-Time Generic Approvals November 2020. The Food and Drug Administration’s rejection of a pair of medicines that Wall Street expected to sail by regulators raised concerns that other upcoming drug decisions could meet a … The FDA has approved the first treatment for COVID-19, the antiviral drug … Upper extremity met primary endpoint, lower extremity trial missed endpoint. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development. It’s no secret that one of the biggest hot-button issue right now and in the upcoming election year is high drug costs. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. This compares to 17 and 4, respectively for the same periods in 2019. The FDA said Saturday that it reissued an emergency use authorization to Quest Diagnostics to use its COVID-19 test with pooled samples. 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. The U.K. approved the Pfizer-BioNTech vaccine just two days ago.The U.S. Food and Drug Administration is slated to meet on Dec. 10 to consider granting regulatory approval.. Drug Name Active Ingredient Approval Date FDA-approved use on approval date* 47. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2020 by the, Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See. Float 9.8M (Small Float) Short Interest 5.28% (Entering Potential Squeeze Area) Current Ratio 27.45 (Financials are strong, debt is extremely small) Additional Info: You must anticipate how the FDA and other agencies will react and address updates in guidelines, regulations and policies. To seal the deal, Bristol Myers agreed to pay Celgene stockholders $9 per share if ozanimod and liso-cel won FDA approval by the end of 2020, and … FDA Approval Calendar, PDUFA Date Calendar, IPO calendar and more tools for trading biotech stocks. On April 15, UroGen Pharma's Jelmyto, the first therapy to treat low-grade upper tract urothelial cancer, was granted FDA approval. 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