FDA
Vinay Prasad, the FDA’s Center for Biologics Evaluation and Research head, is accused of interpersonal impropriety as pushback builds against his decision to reject Moderna’s influenza vaccine candidate.
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The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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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.
Ardelyx, Inc. is lacing up the gloves and preparing to wade into the ring with the U.S. Food and Drug Administration to dispute the July rejection of its chronic kidney disease drug, tenapanor.