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The FDA is requiring a risk evaluation and mitigation strategy (REMS) for Qsymia because of the risk of birth defects from fetal exposure during pregnancy. Read More
The FDA outlined its latest thinking for sponsors of adjuvant therapies for renal cell and bladder cancer in two guidances released yesterday. Read More
In a letter to HHS Secretary Xavier Becerra, 100 members of Congress called for the use of several controversial federal authorities — including compulsory licensing, “march-in rights” and royalty-free rights — to help lower the prices of prescription drugs. Read More
In its latest guidance on patient-focused drug development, released yesterday, the FDA calls for high-quality clinical outcome assessments (COAs) for drug trials. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 19 to 2 yesterday in favor of including a SARS-CoV-2 Omicron component in COVID-19 booster shots. Read More
The Health Resources & Services Administration (HRSA) has contacted drugmaker UBC to admonish the company for limiting its participation in the federal 340B drug discount program, which was designed to serve low-income patient populations in the U.S. Read More
Just ahead of its user fee decision date, Spero Therapeutics was slapped with a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection (cUTI), including pyelonephritis — a type of kidney inflammation with limited oral treatment options. Read More
Gilead Sciences has reached a $33 million settlement with a Florida clinic accused of fraudulently applying to the company’s patient assistance program via homeless people and those in low-wage jobs in order to get access to Gilead’s pricey human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) drugs for free, then selling them on the black market. Read More
For circumstances when drugmakers feel labeling alone isn’t enough to ensure safe selection and use, the FDA is proposing a rule that would expand the pool of nonprescription drugs with “self-selection systems” that would identify the appropriate patients and guide them in taking the medicines safely. Read More