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In a move that may bode ill for the entire class of phosphatidylinositol 3-kinase (PI3K) inhibitors, the FDA has issued a warning against Secura Bio’s Copiktra (duvelisib), citing a 9 percent increased risk of death compared to standard treatment in patients with leukemia and lymphoma. Read More
The FDA’s Office of New Drugs (OND) provides a look into its work with stakeholders to support innovative trial designs in 2021, in its latest yearly report. Read More
Pfizer is jockeying for full FDA approval of its oral antiviral COVID-19 treatment, Paxlovid, which would allow the company to sell the drug commercially. Read More
Netherlands-based Fagron drew a warning letter from the FDA for its facility in St. Paul, Minn., for inadequate equipment cleaning that could lead to cross-contamination of its drug products. Read More
Phase 3 studies of Sanofi’s tolebrutinib in both multiple sclerosis (MS) and myasthenia gravis have been placed on partial clinical hold following reports of drug-induced liver injury in trial participants. Read More
The FDA granted a Breakthrough Therapy designation to olipudase alfa, but it has yet to approve the drug. Nexviadyme, branded as Nexviazyme in the U.S, is already FDA-approved. Read More
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