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The FDA’s accelerated approval program has come under fire again, this time from a group of researchers that found only 38.9 percent of new drugs green-lighted via accelerated approval demonstrated high therapeutic value when compared with existing therapies. Read More
CSL has posted positive phase 3 topline results for garadacimab, a drug designed to prevent potentially dangerous attacks of swelling related to a rare genetic disorder called hereditary angioedema. Read More
Colorado has chosen three supply chain partners to help the state import lower-cost medications from Canada, in anticipation of getting the FDA’s approval to launch the program. Read More
The number of drug units impacted by recalls in the second quarter of 2022 was slashed by more than half — from 435.3 million units recalled in Q1 to 20.6 million — in Q2, the lowest number of units in the past five quarters, according to Sedgwick, a company that specializes in product recalls and remediation. Read More
Astellas Pharma got an FDA green light last week when the agency accepted its New Drug Application (NDA) for fezolinetant — potentially the first-ever nonhormonal drug for hot flashes associated with menopause. Read More
To stretch the available doses, the FDA issued an emergency authorization that allows for a one-fifth dose to be administered beneath the top layer of the skin. Read More