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The FDA has issued a warning letter to Green Wave Analytical for denying the agency’s investigators access to the contract testing laboratory’s San Diego, Calif., facility for the first three days of its inspection and for inadequate testing methods and record-keeping failures. Read More
Amgen’s oral chemotherapy sotorasib significantly improved progression-free survival relative to intravenous docetaxel in patients with previously treated KRAS G12C-mutated nonsmall-cell lung cancer (NSCLC) in a late-stage study. Read More
Novo Nordisk’s Wegovy (semaglutide) was superior when compared to several other weight loss drugs for therapeutic effect, but at an annual cost of $7,500 to $9,800 would require a discount from the wholesale acquisition cost of 44 to 57 percent to make it cost effective. Read More
In the midst of a pandemic, if you wait for all the data to come in, “you’ve missed the boat,” said FDA Commissioner Robert Califf yesterday regarding the agency authorizing both Pfizer/BioNTech’s and Moderna’s bivalent COVID-19 boosters before any clinical trials on them are complete. Read More
Inadequate procedures to minimize the risk of contamination earned Lupin Limited a Form 483 following a March 22 to April 4 FDA inspection of its facility in Palghar, Maharashtra, India. Read More
Neurocrine Biosciences has made a bid for the UK-based Diurnal Group, a move that could pull in a phase 3 candidate for treating congenital adrenal hyperplasia (CAH). Read More