The FDA has issued a third Complete Response Letter (CRL) to Mallinckrodt for the company’s investigational drug terlipressin for the treatment of adults with hepatorenal syndrome (HRS), a life-threatening syndrome…
Boise, Idaho-based Smart Surgical, which does business as Burst Biologics, failed to ensure that its blood products were free of the threat of infection and contamination, the FDA said in…
AstraZeneca and Daiichi Sankyo have released promising results from a phase 3 study of Enhertu (trastuzumab deruxtecan), saying the drug significantly improved both progression-free and overall survival in patients with…
Kodiak Sciences’ antibody designed to treat age-related macular degeneration with eye injections every three to five months was no better than Regeneron Pharmaceutical’s Eylea (aflibercept), the currently approved drug for…
An FDA remote inspection can carry major drawbacks, including that they may last longer than an in-person visit and that the FDA doesn’t consider them to be a full substitute…
The European Medicines Agency (EMA) recommended 92 medicines for authorization by the European Commission in 2021, 53 of which had a new active substance that had not been authorized in…
An FDA inspection of Regeneron Pharmaceuticals’ active pharmaceutical ingredient (API) manufacturing facility in Rensselaer, N.Y., turned up observations of lapses in recordkeeping and cleaning procedures. Source: Drug Industry Daily
Takeda Pharmaceuticals and Code Biotherapeutics are teaming up to develop gene therapies for treatment of rare diseases in a deal that is potentially worth up to $2 billion to Hatfield,…
The FDA has accused two overseas companies of selling unapproved and misbranded drugs for COVID-19 to U.S. customers over the internet. Source: Drug Industry Daily
The FDA’s Office of Pharmaceutical Quality (OPQ) used alternative tools because of the ongoing pandemic that reduced the number of facilities needing pre-approval inspections by more than 50 percent in…