We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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 six years. Read More
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 pill, molnupiravir, co-developed with Ridgeback Biotherapeutics. Read More
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 local governments approve the settlement. Read More
Rumors abound that President Biden is soon to nominate former FDA Commissioner Robert Califf as the nominee to replace acting commissioner Janet Woodcock. Read More
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 about the FDA’s relative transparency. Read More
In January 2020, the FDA issued a notice inviting the drugmakers to petition the agency for a hearing in which they could explain why their ANDA applications shouldn’t be withdrawn. Read More
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 the bill, but likely in a diluted form. Read More
Pfizer/BioNtech’s pediatric vaccine was safe and 90.7 percent effective against symptomatic COVID-19 in children ages five to 11 even when up against the Delta variant over the summer. Read More
Last month, Walensky overrode the recommendations of the advisory committee, which supported a Pfizer/BioNTech COVID-19 booster, but not for adults at high risk of contracting the disease in the workplace. Read More