FDA

Major thyroid med recall underway

September 22, 2020

Both recalls are due to sub-potency of drugs that treat hypothyroidism.

Investigational lymphoma treatment gets FDA nod

August 17, 2020

The drug’s indication for marginal zone lymphoma (MZL) may not be approved until February 2021.

Another pharma maker recalls metformin over NDMA

July 13, 2020

Five other manufacturers have recalled the popular diabetes medication due to the presence of a the carcinogenic ingredient.

Popular HIV-1 med successful, particularly in order adults

July 07, 2020

Gilead will present new data on virologic suppression in adults 65 years and older at AIDS 2020: Virtual this week.

Pharma maker seeks fast approval of lymphoma treatment

June 23, 2020

Investigational treatment will target marginal zone lymphoma (MZL) and follicular lymphoma (FL).

FDA pulls hydroxychloroquine for COVID-19, warns about other drug interaction

June 16, 2020

The agency revoked its emergency use authorization (EUA) for the drug, while warning about a dangerous interaction with remdesivir.

New pediatric HIV med available

June 15, 2020

The unique formulation is a dispersible tablet for children.

New antibiotic for hospital-acquired pneumonia available

June 05, 2020

The agency welcomes another option for serious bacterial infections.

Drug’s indication expanded to reduce heart attack, stroke risk

June 02, 2020

Brilinta is already approved to prevent atherothrombotic events in ASC.

Two metformin products recalled, more on the way

June 02, 2020

Immediately after the FDA said it found elevated levels of the carcinogenic ingredient N-nitrosodimethylamine (NDMA) in certain extended release (ER) metformin products, the first 2 major recalls are underway.