Politics and Policy

Opzelura is first therapy approved to treat patients with vitiligo, a disease that causes the loss of skin color.

Zonisade is the first oral liquid form of zonisamide to be approved by the FDA to treat patients with epilepsy.

Pfizer’s Xalkori is now approved for three indications, with the most recent being ALK-positive myofibroblastic tumors

The FDA has not been able to complete inspections of facilities because of COVID-19 restrictions.

The U.S. government pre-purchases 3.2 million initial doses of the Novavax COVID-19 vaccine.

Bludigo is the first indigotindisulfonate drug product approved by the FDA.

The FDA has assigned a Prescription Drug User Fee Act action date of May 12, 2023, for [vic-]trastuzumab duocarmazine (SYD985).

Piclidenoson is a first-in-class, A3 adenosine receptor agonist small molecule that inhibits the inflammatory cytokines interleukin 17 and 23.

The FDA approved a supplemental BLA for use of Krystexxa with methotrexate for the treatment of uncontrolled gout.

NOV03 (perfluorohexyloctane) is a first-in-class eye drop with a novel mechanism of action. If approved it will be the first to address signs and symptoms of dry eye disease.

Under the national vaccine strategy, the U.S. Department of Health and Human Services is expanding access to the monkeypox vaccine, Jynneos, in areas with the highest transmission and need.

If approved, mosunetuzumab could be the first T-cell engaging bispecific antibody for the treatment of any type of non-Hodgkin’s lymphoma. The FDA has assigned a PDUFA date of Dec. 29, 2022.

Lecanemab is monoclonal antibody that targets beta amyloid to treat mild cognitive impairment. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of Jan. 6, 2023.

The Peripheral and Central Nervous System Drugs Advisory Committee will meet for a second time in September 2022 to discuss new analysis of the data for AMX0035 for the treatment of patients with amyotrophic lateral sclerosis.

Qsymia is only available through a Risk Evaluation and Mitigation Strategy (REMS) program because of the increased risk for birth defects.

NRx Pharmaceuticals had been seeking emergency use for Zyesami for COVID-19 respiratory failure. The company will now focus on clinical research for its therapy for patients with bipolar disorder.

The submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated people at high risk for progression to severe illness from COVID-19.

Palovarotene is being reviewed as a therapy for an ultra-rare disease that transforms the body’s soft tissue into bone. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of Dec. 29, 2022.

The FDA is accepting comments on the proposed rule through Oct. 26, 2022.

Regeneron is seeking an additional dosing regimen with a longer-term interval between doses. The PDUFA date is Feb. 28, 2023.

Spero Therapeutics was seeking approval for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection. The FDA has requested an additional clinical trial.

If approved, lenacapavir would be the first HIV-1 treatment administered twice-yearly.

The trial was an observational study aimed at collecting real-world data on the Alzheimer’s treatment.

Breyanzi is now available as a second-line treatment for this aggressive blood cancer.

Generics of Viibryd, Tranxane and Timoptic have recently been approved and launched.

Elacestrant is oral therapy that targets estrogen receptor 1, a key resistance mechanism in advanced breast cancer.

The FDA approved the combination of Tafinlar and Mekinist for solid tumors with a BRAF V600E mutation. This is the first therapy to be approved that is tumor agnostic for patients with this mutation.

Increased demand for certain medications used to treat hospitalized patients with COVID-19 had a significant impact on medication supply last year.

The company will take no profit, which is part of the company’s bankruptcy filing and settlement with states.

The Cardiovascular and Renal Drugs Advisory Committee meets Nov. 16, 2022, to discuss Xphozah for patients with kidney disease.