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FDA approval alone does not ensure “the optimal administration” of novel treatments like immunotherapy for traditionally underserved populations, according to the authors of a study published in JAMA Network Open. Read More
The pharmaceutical industry spends more on lobbying than any other industry, having shelled out $314 million across about 1,600 lobbyists in 2021, spending almost three times the amount of the next biggest spender in the health sector, hospitals, which spent $116 million on federal lobbying in 2021. Read More
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