Following an FDA priority review, Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, has won U.S. approval as the first drug in the country to treat resistant cytomegalovirus (CMV) infection and disease in adult and pediatric transplant recipients. The drug will be marketed as Livtencity.
The FDA has continued a series of device risk classifications with the formal announcement that general containment systems used with power morcellators will henceforth be deemed class II, moderate-risk devices.
Former FDA Commissioner Stephen Hahn is being asked to spill the beans on political interference at the U.S. agency during the emergence of COVID-19 last year.
The Pan American Health Organization is echoing fears that the COVID-19 pandemic will result in a surge of drug-resistant infections, saying surges already are being seen in several countries in the Americas, including Argentina, Ecuador, Guatemala, Paraguay and Uruguay.
U.S. trading partners are raising concerns about the FDA’s continued delays in inspecting foreign drug manufacturing facilities due to the COVID-19 pandemic and related travel restrictions.
A Chinese patent covering methods and compositions for the use of CRISPR-Cas9 in eukaryotes has been granted to Dublin-based Ers Genomics Ltd., making what Michael Arciero, vice president of intellectual property and commercial development at the company, called “a strong but not surprising statement by China,” which has made the biotechnology industry one of its top national priorities.
The first approval for treating advanced malignant perivascular epithelioid cell tumor (PEComa) in adults has been awarded by the FDA to Aadi Bioscience Inc.’s Fyarro. The number of patients is low, from 100 to 300 patients annually in the U.S., but the geography the company hopes to sell to is wide as it takes in Europe and China.
The FDA gave Pear Therapeutics Inc. a second breakthrough device designation with the company’s Reset-A prescription digital therapeutic (PDT) for alcohol use disorder getting the regulatory agency’s speed pass. The news comes a week out from the vote of stockholders of blank-check company Thimble Point Acquisition Corp. Inc. on a combination with Pear that will take the digital therapeutic company public.
The FDA has issued new risk classification orders for two series of products, including in vitro diagnostics for hepatitis C, two of which the agency down-regulated from class III to class II. However, blood lancets for multiple uses on more than one patient has been elevated from class I to class III, a change that has no impact on any products currently available on the U.S. market.
RSS
