AstraZeneca has scored another win with Imfinzi (durvalumab), showing that the checkpoint inhibitor in combination with standard chemotherapy improved both overall and progression-free survival for patients with advanced biliary tract…
As Congress races to finalize details on President Biden’s signature social spending package by week’s end, a provision allowing Medicare to negotiate prescription drug prices is expected to stay in…
Merck’s investigational once-daily combination pill for HIV has shown positive results in two late-stage trials. Source: Drug Industry Daily
Despite the unprecedented disruption and shift in priorities that COVID-19 brought to FDA’s Office of New Drugs (OND) in 2020, the office approved 53 novel drugs, published 31 new guidances…
In a marked change in policy, the U.S. will send an estimated 4 million doses of AstraZeneca (AZ)/Oxford University’s COVID-19 vaccine to Canada and Mexico, according to a White House…
The European Medicines Agency (EMA) has concluded its evaluation of a small number of blood-clot cases in patients vaccinated with AstraZeneca’s (AZ) COVID-19 vaccine, finding the two-shot inoculation is still…
The FDA approved 17 original abbreviated new drug applications (ANDAs) in the third quarter of fiscal 2020, 14 in the fourth quarter and 18 in the first quarter of fiscal…
Top U.S. health officials, including an FDA regulator testified on Capitol Hill this week that real-world evidence from people vaccinated against COVID-19 and data from ongoing trials will be used…
The Senate confirmed Xavier Becerra as HHS secretary yesterday in a narrow 50-49 vote, with just one Republican siding with Democrats to support his confirmation and the closest vote so…
The UK’s National Institute for Health and Care Excellence (NICE) has decided it will not fund Keytruda (pembrolizumab), Merck’s second-line advanced bladder cancer drug. Source: Drug Industry Daily