Sanofi (SNY) wins FDA label expansion for its MenQuadfi meningococcal vaccine for use in infants as young as six weeks. Read ...

Bayer A.G. ( OTCPK:BAYZF) ( OTCPK:BAYRY) said that an advisory panel of the European Medicines Agency (EMA), endorsed the ...

A label begins with highlights, a succinct, half-page summary of the information that health care practitioners most commonly refer to and view as most important (Figure 2). [4] This section ...

The US FDA has recently proposed a new draft framework that enables pharma manufacturers to add software to a drug label if they can demonstrate that the software adds clinical benefit to the drug.

The drugmaker was supposed to hear back from the FDA on mavacamten at the end of January, but the regulator delayed its deadline to 28 April to allow more time to look at BMS' risk evaluation and ...

Specifically, 52 percent of the decisions were consistent with the FDA label, 9 percent less restrictive, 2 percent mixed (less restrictive in some ways but more restrictive in others), and 33 ...

The effects of mixing up the medications — both help bodies get rid of extra salt and water — depend on the individual but can range from "limited" to "life-threatening," FDA officials said.

such as drone strikes against fentanyl labs or special operations to capture drug kingpins. The criminal groups Trump plans to target are likely to include Mexico’s Sinaloa and Jalisco cartels ...