FDA
Tracy Beth Høeg addressed FDA staffers for the first time in her role as the fifth CDER chief under President Donald Trump, announcing inquiries into the use of SSRIs in pregnancy and RSV antibodies in infants despite well-documented safety of these treatments.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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In writing literally hundreds of stories this year, two BioSpace writers, Alex Keown and Mark Terry, found certain stories particularly intriguing or impactful. Some of those were such big topics that they were covered over a series of stories. Looking back at 2018, here are their Top 10.
The rejection comes about a month after the painkiller was cleared by an FDA advisory committee.
The U.S. Food and Drug Administration (FDA) has issued an approval letter for the new features and intended uses of the Planmed Verity® CBCT scanner. Planmed is very pleased to bring these exciting improvements to the U.S. market.
Late Thursday, Genentech said the U.S. Food and Drug Administration granted regulatory approval for a combination of Tecentriq and Avastin for treatment of some metastatic non-squamous non-small cell lung cancer (NSCLC) patients.
A report from the Government Accountability Office said the FDA failed to live up to the legal requirements when approving drugs under a rare disease designation.
Florida-based Catalyst Pharma won regulatory approval for its treatment of a rare autoimmune disorder called Lambert-Eaton myasthenic syndrome (LEMS). The U.S. Food and Drug Administration approval of the new oral drug, Firdapse (amifampridine), is the first ever approved for this disease.
The FDA approved Xospata for adult AML patients who have a FLT3 mutation as detected by an FDA-approved test. Of the 19,000 people in the United States who are estimated to be diagnosed with AML this year, nearly 40 percent will have a FLT3 mutation.
The U.S. Food and Drug Administration (FDA) gave the green light late Monday to Bayer oncology drug Vitrakvi, a first-of-its-kind TRK inhibitor, after late-stage clinical trial results showed a 75 percent overall response rate and 22 percent complete response rate across various solid tumors.
The U.S. Food and Drug Administration will update its review process for the approval of medical devices in the wake of a report that showed more than 80,000 injuries have been associated with medical devices for pain management since 2008.
AbbVie could be eyeing another potential billion dollars of annual revenue following the accelerated approval of Venclexta for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older or who cannot tolerate intensive chemotherapy.