Houston-based Empower Clinic Services, doing business as Empower Pharmacy, has been sent a lengthy warning letter from the FDA that listed multiple violations — the company’s second warning letter in…
Merck has struck a licensing pact with the Medicines Patent Pool (MPP), a United Nations-supported public health organization serving the developing world, to expand access to its experimental COVID-19 antiviral…
Johnson & Johnson (J&J) has agreed to pay $297 million to Texas by year’s end to settle claims over the company’s alleged role in the state’s opioid epidemic if enough…
Rumors abound that President Biden is soon to nominate former FDA Commissioner Robert Califf as the nominee to replace acting commissioner Janet Woodcock. Source: Drug Industry Daily
Pfizer/BioNtech’s Emergency Use Authorization (EUA) application for a COVID-19 vaccine for young children has cleared its first regulatory hurdle. Source: Drug Industry Daily
The FDA has rejected a citizen petition seeking to revoke the Emergency Use Authorizations (EUAs) of both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines. Source: Drug Industry Daily
The FDA is outperformed by the European Medicines Agency (EMA) and Health Canada when it comes to proactively releasing data on drug approvals, says a new study ― prompting concerns…
Moderna released top line data yesterday from a pediatric study of its mRNA COVID-19 vaccine, which showed a half-dose of the vaccine to be safe and effective in kids ages…
During its third-quarter earnings report, Eli Lilly announced that it’s pursuing accelerated approval for the investigational Alzheimer’s drug donanemab ― and that it also plans to evaluate the therapy compared…
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…