Regulatory
PF-06939926 is currently being evaluated to determine the safety and efficacy of this gene therapy in boys with DMD.
The trial was initially placed on hold in November 2019 due to safety concerns.
Catalyst Pharmaceuticals is reeling this morning after a federal judge dismissed the company’s lawsuit against the U.S. Food and Drug Administration regarding the approval of a rival drug for a rare autoimmune disease from New Jersey-based Jacobus Pharmaceutical.
The company plans to submit its biologic license application (BLA) to China’s National Medical Products Administration (NMPA) and other regulators worldwide.
The new approval makes it the first FDA-approved therapy in over a decade to treat HES and the third indication for the therapy overall.
A team of more than 60 scientists and bioethicists have signed a letter urging Pfizer to wait until late November before the company seeks FDA authorization of its COVID-19 vaccine candidate in an effort to ensure rigorous safety standards have been met.
On Face the Nation, Gottlieb said hospitalization rates in the United States for COVID-19 had been in a state of decline, but those numbers are now rising, which goes hand in hand with an increase in infection rates.
Pennsylvania-based Inovio said the regulatory agency has additional questions about the Phase II/III trial regarding the vaccine candidate itself, known as INO-4800, as well as the company’s Cellectra 2000 delivery device.
During his 2016 campaign, President Trump railed against high pharmaceutical prices, making promises to stand up for Americans who were being “slaughtered” on drug pricing. Now, the FDA has issued a final regulation intended to fulfill Trump’s promises.
The U.S. Food and Drug Administration (FDA) is wrapping up the month of September with a few PDUFA dates. Here’s a look.
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