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The FDA has issued a warning letter to About Mineral, an Orange, Ca-based company that sells Puriton, a direct-to-consumer line of topical skin products which it claims have been tested and are effective against COVID-19. Read More
The FDA has withdrawn five generic opioids from the U.S. market, after three sponsors failed to meet regulatory requirements for their abbreviated New Drug Applications (ANDAs). Read More
The FDA has found deficiencies in the biologics license application (BLA) data submitted for Provention Bio’s teplizumab, a monoclonal antibody being reviewed for delaying or preventing type 1 diabetes, and the agency’s evaluation of it is likely to be delayed as a result, the company said. Read More
In more bad news for AstraZeneca, the European Medicines Agency (EMA) announced that its safety committee is investigating reports of capillary leak syndrome, a rare, potentially life-threatening disorder, in individuals inoculated with the company’s COVID-19 vaccine. Read More
Emergent BioSolutions’ beleaguered Baltimore, Md., facility, which Johnson & Johnson has taken over to exclusively produce its vaccine, may be cleared to start shipping out J&J doses before the month is over, according to the White House’s COVID-19 response leader. Read More
The Biden administration has sent a budget proposal to Congress, outlining its spending priorities for fiscal year 2022, but it sheds almost no light on the president’s plans to fund FDA initiatives. Read More
Biogen and Chinese drugmaker Bio-Thera Solutions have teamed to develop a biosimilar of Roche’s Actemra (tocilizumab), BAT1806, currently being evaluated in phase 3 trials for moderate-to-severe rheumatoid arthritis. Read More
The FDA has approved a new, biweekly dosing regimen for ImClone’s cancer drug, Erbitux (cetuximab), for patients with a certain form of EGFR-expressing colorectal cancer or head and neck squamous-cell carcinoma. Read More
The FDA has granted full approval for Immunomedics’ Trodelvy (sacituzumab govitecan-hziy) for treating women with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior lines of therapy. Read More