The U.S. Food and Drug Administration approved Gilead Sciences’ antiviral therapy Veklury (remdesivir) as the first treatment for COVID-19 in young children.

Gilead Sciences Inc. said on April 11 the U.S. Food and Drug Administration had lifted the partial clinical hold placed on the company’s trials testing a blood cancer drug combination.

Three companies – Intellia Therapeutics, Editas Medicine and uniQure – are each anticipating a bright 2022 as the promises of gene therapy continue to be realized.

The U.S. Food and Drug Administration held a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on Avenue Therapeutics’ IV tramadol. 

At WORLDSymposium, Astellas Pharma presented interim safety data from a Phase I/II study assessing the company’s AAV gene therapy for the rare, autosomal metabolic disease Pompe disease.

The inexpensive antidepressant fluvoxamine might help keep patients with Covid-19 from developing severe disease, according to a study published in The Lancet Global Health. Researchers found in another study that the coronavirus can infect cells of the inner ear, which may help explain the balance problems, hearing loss and tinnitus (ringing in the ears) experienced by some Covid-19 patients.

A booster dose of the Covid-19 vaccine developed by Pfizer Inc. and German partner BioNTech SE restored efficacy to 95.6 percent against the virus, including the Delta variant, data released by the companies from a large study showed on Oct. 21.

French specialty vaccine company Valneva and U.S. drugmaker Pfizer reported positive results from the companies’ Phase II study on a vaccine candidate for Lyme disease.

Initial results from a vaccine trial reported Sept. 20 showed that Pfizer and BioNTech’s Covid-19 vaccine might be safe for use in children under 12 years old. 

Theravance announced that the diversified biopharmaceutical company’s oral drug candidate for the possible treatment of ulcerative colitis failed to meet the primary endpoint of a Phase IIb study.