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To help clear up confusion about the Drug Supply Chain Security Act (DSCSA) enhanced drug distribution security requirements that will go into effect on Nov. 27, 2023, the FDA has issued two draft guidances that detail matters related to trading partners and electronic reporting. Read More
Faced with a barrage of pleas from both clinicians and patients, the FDA will hold a second expert panel hearing on Amylyx’s AMX0035, a drug intended to treat amyotrophic lateral sclerosis (ALS). Read More
AstraZeneca is buying TBio subsidiary TeneoTwo, which will shore up its hematology pipeline with TeneoTwo’s candidate for relapsed and refractory B-cell non-Hodgkin lymphoma. Read More
Three big drug U.S. distributors accused of fueling the opioid crisis in West Virginia’s Cabell County and the city of Huntington were let off on Monday as a U.S. District judge ruled that they were not to blame. Read More
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