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A study of drugs granted accelerated approval by the FDA between January 2012 and July 2021 found that more than half of the required confirmatory trials missed their deadlines. Read More
The Center for Biologics Evaluation and Research (CBER)’s ability to hire and retain staff will be a key challenge for fiscal 2024, according to Peter Marks, the center’s director, who spoke last week at an Alliance for a Stronger FDA webinar. Read More
A federal appeals court has cleared the way for PhRMA’s complaint against Minnesota’s plan to have manufacturers provide insulin for free to move forward. Read More
The FDA has withdrawn its approval of Makena, Covis Pharmaceutical’s drug to reduce the risk of pre-term birth in at-risk women, citing the lack of a favorable postmarket benefit-risk assessment and ending Covis’ hopes for an “orderly wind-down” period. Read More
Arbutus Biopharma and Genevant Sciences have filed a complaint in a federal court alleging that Pfizer and BioNTech violated five patents related to their messenger RNA (mRNA) delivery technology used in the Pfizer/BioNTech COVID-19 vaccine. Read More
The European Medicines Agency (EMA) is updating its Priority Medicines (PRIME) program to include new ways to track a product’s progress toward approval and to get more timely advice from the agency. Read More
Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), explained her center’s top budget priorities for fiscal 2024 — highlighting steps to shore up the drug supply chain and improve generics availability — yesterday at an Alliance for a Stronger FDA webinar. Read More
In a move to help prevent or mitigate shortages, the FDA is asking drugmakers to provide more information regarding manufacturing disruptions that could affect finished drugs and biological products as well as some active pharmaceutical ingredients (API). Read More
AdvaMed has submitted an amicus brief to the U.S. Supreme Court in support of two supermarket chains accused of violating the False Claims Act by misreporting their drug prices, arguing that the errors were due to complex and sometimes conflicting regulations. Read More
In its latest move to address the opioid overdose crisis, the FDA is requiring opioid manufacturers to provide prepaid mail-back envelopes to outpatient pharmacies and other dispensers to make it easier for patients to dispose of unused opioids. Read More