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October 30, 2018
Mylan announced the launch of its biosimilar to AbbVie’s Humira across major European markets.
October 26, 2018
A new proposal aims to reduce reimbursement for medicines administered to seniors under the Part B benefit to an amount pegged to the average price paid in foreign industrial nations.
October 24, 2018
The agency has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza.
A federal court judge ordered Keystone Laboratories, Inc. of Memphis, Tennessee to stop selling over-the-counter drug products.
October 23, 2018
The agency, in partnership with international regulatory and law enforcement agencies, cracked down on 465 websites marketing illegal opioids and other drugs claiming to treat conditions such as cancer and HIV.
Takhzyro (lanadelumab) is the first monoclonal antibody therapy approved for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
October 19, 2018
To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.
October 18, 2018
The US Department of Health and Human Services has published its proposed rule on the disclosure of drug prices, just in time for the November mid-term elections.
October 16, 2018
The agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway.
The guidance describes the agency's recommendations on how to group patients with different molecular alterations and approaches for evaluating the benefits and risks of targeted therapies where some molecular alterations may occur at low frequencies.