Politics and Policy

An FDA decision is expected in late 2022.

If approved, maribavir would be the first therapy to treat transplant patients with cytomegalovirus.

Merck plans to seek emergency use authorization for molnupiravir as the first oral treatment for COVID-19.

AstraZeneca’s long-acting antibody combination has been shown to reduce the risk of developing symptomatic infection.

Data show that the vaccine was 94% effective against moderate infection and 100% effective against severe disease.

Tecartus is the first CAR T-cell therapy approved to treat adults with relapsed or refractory ALL.

Livmarli is the first drug approved for Alagille syndrome.

The company has also launched a website for patients affected by hereditary angioedema, a rare genetic disorder.

Half of the 14 oncology indications approved in the second quarter were accelerated approvals.

This is the seventh approval for Erbitux and the only anti-EGFR antibody approved for this indication.

The PDUFA target action date for the FDA decision is Jan. 30, 2022.

AbbVie’s Qulipta is a once-daily oral to prevent migraines in adults.

The companies plan to request an emergency use authorization in a few weeks.

The companies are seeking accelerated approval based on the surrogate end point of beta amyloid reduction.

The FDA assigned a Prescription Drug User Fee Act goal date of May 28, 2022.

Repatha is now available for children 10 and older to lower low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolemia.

This is the fourth approval for Jakafi, a JAK1/JAK2 inhibitor.

People over the age 65 and those at high risk of severe COVID-19, including health care workers and those with occupational exposure, are eligible for the booster.

Dr. Reddy’s has also launched a generic of Librax. Recent generic approvals include clindamycin phosphate foam and sodium acetate.

Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States.

Tivdak is the first approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer.

The FDA assigned a PDUFA action date of March 20, 2022, for ganaxolone.

In trials, Skyrizi demonstrated improvements in clinical remission and endoscopic response as both induction and maintenance therapy

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.

Biogen/Samsung Bioepis’ Byooviz is a biosimilar of Genentech’s Lucentis.