FDA Announces Installation Fee for Over-the-Counter Drug Manufacturers
On Friday, March 26, 2021, the FDA issued a Federal Register notice, "Fee Rates under the Non-Prescription Drug User Fee...
Month: March 2021
Indian drug maker fined $ 50 million
Fresenius Kabi Oncology Limited owned and operated a manufacturing facility in Kalyani, West Bengal. Indian drug maker fined $ 50...
Indian Cancer Drug Maker To Pay $ 50 Million For Cover Up, Destruction Of Records Before FDA Inspection | Takeover bid
Indian drug maker Fresenius Kabi Oncology Limited (FKOL) fined and forfeited $ 50 million after pleading guilty to concealing and...
COVID-19: NJ’s drugmaker Merck says new antiviral drug shows rapid reduction in virus
The investigational antiviral drug molnupiravir developed by New Jersey drugmaker Merck with Ridgeback Bio shows rapid reduction in infectious virus...
FDA and drugmaker withdraw indication for Keytruda for small cell lung cancer
Merck - the manufacturer of Keytruda (pembrolizumab) - is withdrawing the drug indication for immunotherapy for patients with metastatic small...