Regulatory
The U.S. Food and Drug Administration had a busy week leading up to the Labor Day holiday. Here’s a look at the agency’s recent activities.
The FDA is keeping busy as summer winds down, with approvals, Orphan Drug Designations and other actions. Here’s what the agency has been up to this week.
The United States and China are reportedly close to an agreement that would allow the PCAOB to audit companies listed on the U.S. stock exchange, per the Wall Street Journal.
AstraZeneca announced a series of wins in Japan with regulatory approvals for Tagrisso, Ultomiris and Lynparza, to treat non-small cell lung cancer, myasthenia gravis and breast cancer, respectively.
BioMarin’s Roctavian was granted conditional authorization in the European Union, making it the first gene therapy approved for severe hemophilia A. Now, the company is shooting for U.S. approval.
Of the 1,400 jobs Novartis plans to eliminate in Switzerland, about half will include leadership and management positions, the company reported Monday.
Shares of Foghorn are tumbling after the FDA placed a full clinical hold on a Phase I dose escalation study that had already been subject to a partial hold following a patient death.
Drug development can be done better, faster and less expensively. The industry is facing up to that reality, moving a variety of disruptive innovations forward with the blessing of regulators.
Cases of monkeypox infections reported in the latest viral outbreak have surpassed 14,000 in the U.S., according to the CDC. Some scientists believe the outbreak was predictable.
HHS found nearly half of NIH clinical trials were reported incorrectly, in violation of federal standards, according to a new report issued Friday by the agency.
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