Regulatory
Sigilon Therapeutics announced it may have discovered the reason why its experimental cell therapy treatment for severe hemophilia A was placed on clinical hold by the FDA.
Shares of Kura Oncology have plunged nearly 30% in premarket trading after the FDA placed a partial clinical hold on the company’s Phase Ib leukemia study following the report of a patient’s death.
The FDA approved Takeda’s Livtencity (maribavir) for adults and children 12 years or older with post-transplant cytomegalovirus (CMV) infection.
Tonix expects to begin enrollment in the trial for TNX-1900, an intranasal potentiated oxytocin, during the second half of 2022.
The U.S. FDA is making up for Covid-lost time this year, doubling the goal for FY 2021 domestic surveillance inspections for food and medical manufacturing facilities.
The U.S. Food and Drug Administration approved COVID-19 vaccine booster shots for all Americans ages 18 and over Friday morning.
The FDA and CDC will soon decide on Pfizer-BioNTech’s request for an Emergency Use Authorization for the booster shot for their COVID-19 vaccine.
Iterum Therapeutics will head back into the clinic to meet regulatory requirements to refile a New Drug Application for oral sulopenem.
While COVID-19 appears to be surging again in the U.S. and Europe, the government is spending billions to acquire antibody and antiviral therapies and edging toward vaccination boosters.
Pfizer’s oral antiviral treatment for COVID-19 is making its way through regulatory hurdles. The company is working with global manufacturers to ensure a steady supply of the medication.
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