News

The FDA has approved a hepatitis B therapy for adolescents and an oral MEK inhibitor to treat blood cancers. The regulatory agency has granted priority review for an adult RSV vaccine but extended the review for a Pompe disease therapy. Additionally, CytoDyn has withdrawn its BLA for an HIV therapy.

The FDA approved two new novel cancer treatments: a bispecific antibody for multiple myeloma and a regimen of two drugs for liver cancer. The agency also granted priority review to two therapies. One is a novel therapy for C. difficile and the other is for a acute myeloid leukemia drug. The FDA has postponed an advisory committee meeting for an OTC birth control pill and accepted an NDA for new dry eye therapy. Additionally, Genmab submitted applications for a bispecific therapy for large B-cell lymphoma.

Three more cities join the 100-plus others that have endorsed the Medicare for All legislation. City Councils in Denver, Colorado, Gainesville, Florida, and Kent, Ohio passed the resolution in support of the universal program that ends for-profit healthcare.

In COVID-19 news, the FDA issued an EUA for Novavax booster. The agency has extended review time for new ALS therapy and accepted a supplemental NDA for Camzyos. Additionlly, the FDA granted six months pediatric exclusivity for Eylea.

In COVID-19 news, the FDA has authorized updated boosters for younger children. The FDA also approved an at-home heart failure therapy, but issued a CRL for a Parkinson’s therapy. The agency has assigned PDUFDA dates for several BLA, including a hemophilia A gene therapy and Eylea for retinopathy in premature infants. Regulators have also announced an Adderall shortage. Additionally, a nonprofit company has begun the application process for OTC version of naloxone.

Marc Samuels and Lindsay Bealor Greenleaf of ADVI Health, LLC, say right now may not be the best time to move forward with this law as it could increase inflation through 2024. Samuels is CEO and founder of ADVI Health and is a member of MHE's editorial advisory board. Greenleaf is vice president and head of policy and reimbursement at ADVI.