Tag Archive for: pediatrics

The amended authorization is for children six months through four years of age who have completed their initial three-dose vaccination with Pfizer’s original shot.

The rare disease biotech announced the FDA has accepted its supplemental New Drug Application to expand Voxzogo (vosoritide) to children younger than five years.

Nelarabine Injection ensures access to a lifesaving treatment that historically has been in shortage.

Although nearly all the countries in Europe are reporting shortages, the EMA is not going to label the ongoing shortage of antibiotics in the continent a “major event”, according to a source familiar with the matter.

The letter sent to the European Medicines Agency comes as antibiotics, including amoxicillin – used to treat bacterial infections and often prescribed for ear and chest infections in children – have been in short supply since October.

Kroger joins pharmacy chains CVS Health Corp and Walgreens Boots Alliance Inc., which have also limited purchases of children’s pain medicines at a time when U.S. flu hospitalizations have jumped to the highest in a decade for this time of year.

Both companies’ vaccines produced antibodies 14 days after the first of two shots and were detectable at varying levels in both children and adults for one year, data from the studies conducted in Western Africa showed.

The company was seeking approval of omburtamab to treat a rare form of nerve cancer in pediatric patients. The FDA’s decision follows a unanimous vote in October against the drug to treat neuroblastoma due to insufficient evidence that it improves overall survival.

The head of the panel of 18 appointees, known as STIKO, said there was no clear case for broad use, citing a lack of data to rule out any rare side effects and no signs of the infection causing severe illness in otherwise healthy children.

There are no U.S. approved vaccines for RSV, a common virus that typically causes mild cold-like symptoms but can be fatal for young kids and older adults. RSV is estimated to cause about 14,000 annual deaths among older adults in the United States.