FDA is launching a new resource to assist external and agency researchers collecting historical information about FDA’s drug approvals. The Compilation of Center for Drug Evaluation and Research FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. New Drug Approvals. The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved. See also: Generic Approvals, Approval Process, New Indications and Dosage forms. Get news by email or subscribe to our news feeds. Novel Drug Approvals for 2019. Innovation drives progress. 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. PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced. Also, usually biostocks experience a run-up going into the scheduled decision/review dates. So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks.
New Drug Approvals. The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved. See also: Generic Approvals, Approval Process, New Indications and Dosage forms. Get news by email or subscribe to our news feeds. Novel Drug Approvals for 2019. Innovation drives progress. 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. PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced. Also, usually biostocks experience a run-up going into the scheduled decision/review dates. So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks. The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
21 Jan 2019 A peak in FDA drug approvals came as companies increase their expects approvals to stay at that high level “for the foreseeable future,”
11 Jan 2019 Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018. 1 Jan 2018 Castleski/Shutterstock.com The small number of new drug approvals in 2016, only 22 (1), may have been an anomaly. As of Nov. 14, 2017
Biotech Stock Catalyst and FDA Calendar for your biotech stock investing. Use our tools on your road to profit in the stock market. Biotech stocks with key binary events/catalysts - FDA Approval/PDUFA dates, Advisory Committee and Phase 2 & 3 trial data releases dates are noted. Phase 1 catalysts for small-cap companies only are listed. For prescription brand-name drugs, Drugs@FDA typically includes the most recent labeling approved by the FDA (for example, Prescribing Information and FDA-approved patient labeling when available), regulatory information, and FDA staff reviews that evaluate the safety and effectiveness of the drug. FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the New Drug Approvals. The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved. See also: Generic Approvals, Approval Process, New Indications and Dosage forms. Get news by email or subscribe to our news feeds. All News; Consumer; Pro; New Drugs; Pipeline; Clinical Trials; More With FDA approval deadlines approaching in 2020, these four drug developers could see substantial gains if they're successful. 4 Healthcare Stocks With FDA Approvals on the Horizon | The Motley Fool Former FDA Commissioner Dr Robert Califf expressed concerns over President Donald Trump’s stated plans to speed up drug approvals and significantly reduce FDA regulations. In an interview with Kaiser Health News , Dr Califf––who stepped down from the agency just last month––shared his takeaways about ensuring that safety is maintained