Approvals
Shares of Aadi Bioscience were up more than 25% in premarket trading after announcing the FDA greenlit its treatment for a rare and aggressive form of cancer that disproportionately affects women.
The FDA has granted Cambridge-based bluebird Bio a Priority Review of its Biologics License Application for betibeglogene autotemcel (beti-cel).
The U.S. Food and Drug Administration has a few PDUFA dates for the Thanksgiving Holiday week. Here’s a look.
BioMarin Pharmaceutical scored a first on Friday and provided an option for patients with a rare disease for which there is little recourse.
The U.S. Food and Drug Administration approved COVID-19 vaccine booster shots for all Americans ages 18 and over Friday morning.
The extension will give the FDA sufficient time to look into the drug for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
Monoclonal antibodies have proven to be an important therapeutic option in the ongoing battle against COVID-19.
Merck’s Keytruda (pembrolizumab) keeps expanding the indications for which it’s approved. The company announced today that the FDA had approved the anti-PD-1 therapy for adjuvant treatment of renal cell carcinoma.
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.
The research showed that 61% of patients with PV experienced a complete hematological response after 7.5 years of treatment with BESREMi. Here’s more about it.
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