Politics and Policy

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.

The approval comes more than two months ahead of its PDUFA target date of December 4, 2021.

The vaccines advisory committee voted late on Friday, September 17, 2021, to provide emergency authorization of Pfizer’s COVID-19 vaccine as a booster for those over the age of 65, as well as for those at high risk of developing severe disease.

Rinvoq achieved primary and secondary end points compared with placebo.

The combination of bamlanivimab/etesevimab can now be given to both treat and prevent COVID-19 infection after exposure.

Takeda Oncology’s Exkivity treats non-small lung cancer in patients with EGFR exon 20 insertion mutations. This is the second approval for this mutation and the first oral therapy.

The FDA has set a Prescription Drug User Fee Act target action date of April 30, 2022.

The agency has granted accelerated approval to Brukinsa as a second-line treatment for patients with marginal zone lymphoma, a group of slow-growing non-Hodgkin lymphomas.

The PDUFA date has been set for July 12, 2022.

Jardiance demonstrated a 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure.

Officials with OptumRx predict four new therapies that are expected to an impact on patients and on the market.

The therapy, to be launched in October, is delivered quickly to the bloodstream by targeting the upper nasal space.

The CDC and the FDA have updated their recommendations for the 2021-2022 flu season.

The FDA’s review of the JAK inhibitor class concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with these arthritis and ulcerative colitis medicines.

Investigators says Janssen’s Invega Hafyera offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence.