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The following calendar covers most of the expected drug approval decisions by the FDA through the end of the year. Drug/indication: Acapodene for prostate cancer. FDA Approves Tecartus (brexucabtagene autoleucel) as the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma - July 24, 2020; Tecartus FDA Approval History; Xeglyze (abametapir) Topical Lotion.
Drug/indication: Pralatrexate for peripheral T-cell lymphoma. 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. FDA Approval Calendar and Finding Potential FDA Approval Catalyst Dates BioPharmCatalyst provides a pharmaceutical data bank that keeps track of Biotech stocks, FDA approvals, Advisory Committee activity and Phase 2 & 3 Trial data. Zenpep is a pancreatic enzyme replacement product for patients with pancreatic insufficiencies, a condition associated with cystic fibrosis, chronic pancreatitis and other diseases. News, Stock Find and follow all COVID-19 clinical trials. FDA approval is a lengthy process and several issues may crop up along the way. Key Wallstreet Copyright © 2020 RTTNews. Spectrum has a new FDA approval decision date following a July 5 request from the agency for additional clinical data. 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. Home . Also, usually biostocks experience a run-up going into the scheduled decision/review dates.
These can be make-or-break events for drug and biotech companies, so naturally, FDA decisions often move stocks significantly. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.
Notice that the advisory panel's review of Xiaflex is scheduled for after the FDA approval decision date, which likely means a delay. 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. Now, an updates of recently announced FDA approval decisions: The FDA declined to approve Krystexxa, citing concerns about the way the drug is manufactured. Sign Up Log In. 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). PDUFA dates for biotech stocks. Calendar, Drug Savient plans to respond to the FDA's concerns in early 2010. The site is secure. Qutenza is a skin patch that delivers a form of capsaicin through the skin to alleviate nerve pain.
Calendar, Drug This calendar tracks upcoming PDUFA drug approval dates and FDA advisory committee meetings. research product, JNJ Begins Phase 3 COVID-19 Vaccine Trial, Another Headstone In Alzheimer's Graveyard, PFE On Watch, Pre-market Movers In Healthcare Sector: POAI, ACET, GNCA, WVE, NAOV…, Pre-market Movers In Healthcare Sector: ANPC, SAVA, FLGT, RMTI, ONTX…, Ethos Cannabis Enters Maryland Market By Acquiring Rights To 4Front Dispensaries, HHS Announces $360 Mln Funding Towards Maternal And Child Health, COVID-19 Death Toll In US Crosses 200,000. FDA Takes Action to Address Coronavirus Disease 2019 (COVID-19) FDA is working with U.S. Government partners, including CDC, and … So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks. News, Key Wallstreet The FDA review of telavancin for complicated skin and skin structure infections was delayed by the agency's request for additional information. Company: Dr. Reddy's Laboratories, Inc. This limited demo only displays Phase 3 trials with primary completion dates within the last 3 months for companies with a market cap less than $1B. The PDUFA date refers to the date the Food and Drug Administration (FDA) are expected to deliver their decision whether or not a approve a companies New Drug Application (NDA) … Biotech Stock Catalyst and FDA Calendar for your biotech stock investing.