FDA
Excerpt from the Press Release: Moderna Inc. plans to double enrollment in a trial of its Covid vaccine in children under age 12, following a request from U.S. regulators to collect additional safety data. Moderna’s study will enroll an estimated 13,275 participants ages 6 months up to 12 years old, according to a listing on the clinicaltrials.gov website. In a…
Excerpt from the Press Release: TOLEDO, Ohio & PHILADELPHIA–(BUSINESS WIRE)–NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of Clinlogix, a leading, Philadelphia-based global clinical research organization. Third in an advancing series, this acquisition follows NAMSA’s purchase announcements of Syntactx and American Preclinical Services (APS) in early…
Excerpt from the Press Release: RADNOR, Pa.–(BUSINESS WIRE)–Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of its lead product candidate ganaxolone, to treat seizures…
Excerpt from the Press Release: Vaxart (NSDQ:VXRT) announced today that the FDA cleared the investigational new drug (IND) application for its oral COVID-19 vaccine. Upon news of the IND application approval for the S-only protein construct-based vaccine candidate, shares of VXRT were up 16.1% at $8.35 in early-morning trading today. Click the button below to read…
Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Aug. 2, 2021 /PRNewswire/ — Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines administered by tablet, announced today that the U.S. Food and Drug Administration has cleared Vaxart’s Investigational New Drug application for an S-only oral tablet SARS-CoV-2 vaccine candidate. “This is great news because it allows us to move forward…
Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Magenta Therapeutics, Inc. (Nasdaq: MGTA) today announced that it has received a clinical hold letter from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug Application (IND) filed in June 2021 to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with acute…
Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Lyndra Therapeutics, a clinical-stage biotechnology company working to make daily pills a thing of the past, today announced the positive outcome of an end-of-phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) providing a clear path to approval for Lyndra’s Weekly Risperidone (LYN-005), the company’s…
The FDA has released a new Action Plan on Artificial Intelligence/Machine Learning (AI/ML)- Software as a Medical Device (SaMD). You can download it below by clicking the button! Download The Action Plan
In March of 2019 the FDA released this statement regarding the value of Expanded Access Programs and the FDA’s encouragement of Sponsors to consider providing them as options for Patient Populations. A few interesting statements worth highlighting in the statement: “Since 2010, drug sponsors and manufacturers have given the opportunity of such access to more…
- « Previous
- 1
- …
- 22
- 23
- 24