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.

FDA approves med for severe malaria

May 28, 2020

IV artesunate is the only drug available in the U.S. to treat the disease.

Top 3 COVID-19 stories this week

May 19, 2020

FDA authorizes first stand-alone, at-home test, plus other top COVID-19 news stories.

FDA clears new antigen, saliva tests for COVID-19

May 11, 2020

Antigen tests, a new category, have a major advantage and disadvantage over COVID-19 tests already approved.

FDA: Fraudulent COVID-19 medical products abound

May 11, 2020

Numerous PPEs and testing kits also feature unproven coronavirus claims.

New subcutaneous multiple myeloma treatment available

May 05, 2020

Formulation could cause fewer administration-related reactions than IV Darzalex.

FDA restricts hydroxychloroquine use, plus other COVID-19 updates

April 27, 2020

Agency says the anti-malaria drug can cause heart rhythm problems.

FDA warns CBD companies making medical claims

April 27, 2020

Suppliers claim CBD can help alleviate opioid addiction, cure diseases.

New lung cancer treatment launches

April 21, 2020

The drug, plus chemotherapy, shows a significant survival benefit.

FDA expands hepatitis C treatment to children

March 24, 2020

Clinical trial results were similar to those of the drug in adults.