In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to expand Talzenna into a broader prostate cancer population has failed to impr | Eight outside experts on the FDA’s Oncologic Drugs Advisory Committee delivered a unanimous ‘No’ vote on the question of whether Pfizer’s PARP inhibitor Talzenna has a favorable benefit-risk profile in metastatic castration-resistant prostate cancer patients without homologous recombination repair gene mutations.

The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in patients with prostate cancer who do not carry HRR mutations.

According to the CDC, cases of myocarditis and pericarditis are rare with the vaccines and, in most cases, resolve within a few days of dosing. None of the companies involved have commented on the change in the warning text.

The U.S. Food and Drug Administration approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay.

One possible explanation for the gap is the availability of highly efficacious CAR-T therapies in the U.S. and Europe serving as later-line therapies to improve survival outcomes. The FDA has also approved CAR-T therapies specifically for second-line treatment.

Pfizer's 7.45% dividend yield can't offset weak growth, declining EPS, and patent risks. Read more on PFE and why analysts warn of bearish trends.

The U.S. Food and Drug Administration has granted limited approval to Novavax Inc.'s COVID-19 vaccine, restricting its use to people 65 and older and those 12 and up with underlying health conditions that increase risk of severe illness.