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Merck said it plans to launch two large phase 3 trials of its oral COVID-19 antiviral candidate MK-4482 in September and is also moving ahead with trials of two potential vaccines. Read More
Sanofi and GlaxoSmithKline (GSK) have secured a $2.1 billion U.S. government contract to develop and produce 100 million doses of their COVID-19 vaccine candidate. Read More
Sponsors of drugs and biological products for preoperative treatment of high-risk early-stage breast cancer can qualify for the FDA’s accelerated approval pathway if they use pathological complete response (pCR) as an endpoint, according to a final guidance released last week. Read More
The FDA has unveiled its user fees for prescription drug applications for fiscal year 2021 — slightly trimming some fees that increased by double digits for fiscal 2020. Read More
In a new guidance on unit-dose repackaged solid oral drugs, the FDA said it will generally not take action on nonconformance with requirements for expiration dating if certain requirements are met. Read More
The FDA handed Georgia-based contract manufacturer Pharma Tech Industries a Form 483 for good manufacturing practice violations at its Royston facility, including the release of drug products before obtaining test results and insufficient complaint investigations. Read More