FDA
The Inflation Reduction Act contains provisions designed to influence drug prices. These policies might affect drug development and the prioritization of new drugs.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
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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.
Pfizer and BioNTech requested the FDA authorize booster shots for their COVID-19 vaccine for all adults 18 years and older, presenting data not available in September.
Mid-November is a relatively quiet period for the U.S. Food and Drug Administration in terms of its scheduled PDUFA dates. Read on for more.