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A new draft guidance from the FDA provides a variety of recommendations for the content of drug dosage and administration labeling, including information on dosage range, risks related to drug handling, concomitant treatments, specific populations and missed doses. Read More
A nonprofit physicians’ group has issued a statement calling for a full vetting of Eisai’s Alzheimer’s disease drug Leqembi (lecanemab) in an FDA advisory committee meeting before the agency makes any decision on full approval. Read More
Sandoz received bad news Tuesday when a federal appeals court affirmed the FDA’s decision to deny its challenge and grant Sanofi the exclusive right to market the blockbuster multiple sclerosis drug Aubagio. Read More
India-based Biocon Biologics has received a Complete Response Letter (CRL) from the FDA calling for more data on its biologics license application for a form of regular insulin (insulin-R) and evidence the company has resolved manufacturing problems uncovered in a preapproval inspection. Read More
Indian generics company Sun Pharmaceutical Industries took another hit from the FDA, receiving an FDA warning letter after the company failed to adequately address the agency’s concerns over lapses in aseptic procedures, inadequate media fills, poorly designed and ventilated cleanrooms, and flaws in vial-filling machinery. Read More
More than two dozen lawmakers are asking HHS Secretary Xavier Becerra to lower the cost of Xtandi (enzalutamide), a pricey androgen-blocker developed by Astellas and Pfizer used as maintenance therapy for people with prostate cancer. Read More
A federal court has declared that HHS may determine how it will pay back the more than $1 billion it owes hospitals for years of underpayments related to the 340B drug discount program. Read More
The U.S. Court of Appeals for the First Circuit said that it will not revive several hundred lawsuits accusing GSK of failing to warn female patients that its anti-nausea therapy Zofran (ondansetron) could induce birth defects. Read More
Otsuka and developmental partner Lundbeck have snagged FDA priority review of their supplemental new drug application (sNDA) for Rexulti (brexpiprazole) as a treatment for agitation in people with Alzheimer’s disease. Read More