Christine Blank

Moderna is also studying booster doses of the COVID-19 vaccine for all pediatric cohorts.

Veklury gets full approval for use in children and the Biden Administration commits to expanding the Test-to Treat initiative and getting COVID-19 anti-virals to those who need them.

The World Health Organization now recommends Paxlovid and Veklury for non-severe COVID-19 at high risk of hospitalization but still advises against use in mild disease with low risk of hospitalization.

The FDA has granted orphan drug designation to a potential first-in-class therapy for scleroderma and a PD-1 inhibitor for small cell lung cancer.

The InspectIR Systems Breathalyzer test can provide results in three minutes.

The generic cysteine could be available after a ruling in a patent dispute, which is expected in the third quarter of 2022.

Review of 28 studies suggests role for CBD and THC as therapy for MS but evidence base needs to be stronger.

Researchers say kappa free light chain tests would be less costly and produce results sooner than the oligoclonal band tests.

CMS’s final decision is that monoclonal antibodies to treat Alzheimer’s disease may only be covered in a randomized controlled trial conducted under an investigational new drug application.

A phase 3 trial is expected to begin by the end of the second quarter.

The prevalence of nonalcoholic fatty liver disease (NAFLD) is significantly higher in men (33%) than women (20%).

The FDA is asking for nearly a 34% increase over the agency's fiscal year 2022 funding level.

The FDA determined that the benefits of the second booster dose outweighed the risks after reviewing data from Pfizer, BioNTech, and Moderna.

The FDA has okayed allowing patients to start treatment with the injection instead of having a lead in with the oral version.

Some generics have as much of a 10,000-times increase from the manufacturers weighted average manufacturers price to what a patient could pay at the pharmacy if they chose to pay the cash price.

Opdualag is a first-in-class immunotherapy that combines Opdivio with the novel LAG-3-blocking antibody relatlimab.

New data show longer-term benefits from Aduhelm, which was approved last year to treat Alzheimer’s disease.

B. Braun is recalling five lots because of fluid leakage, which could expose patients to a bacterial or fungal infection.

This expands commercial coverage to 118 million lives and Medicare coverage to 7.1 million lives.

This is the first generic available for Revlimid in the United States.

Amneal Pharmaceuticals received approval for Releuko to decrease incidence of infection after chemotherapy.

Vonjo is the first treatment first approved therapy that specifically addresses the needs of patients with cytopenic myelofibrosis.

The interplay between nonalcoholic fatty liver disease and diabetes can amplify both conditions, say two prominent researchers.

FDA approved Legend Biotech’s chimeric antigen receptor T-cell (CAR-T) treatment, Carvykti (ciltacabtagene autoleucel; cilta- cel), to treat relapsed or refractory multiple myeloma (RRMM) who have received four or more prior lines of therapy.

Agency says evidence points to Evusheld being more effective against omicron variants if doses are doubled.

The new indication for reducing the risk of cardiovascular death and hospitalization for heart failure is expected to boost Jardiance’s sales further. Revenue for the drug jumped 38% in 2021 to reach nearly $432 million globally.

Sanofi and GSK today announce will try to get approval from the FDA and the European Medicines Agency (EMA) for their COVID-19 vaccine, entering a crowded market.

The FDA’s authorization would depend on ongoing studies establishing that a fourth dose would shore up people’s molecular defenses that waned after their first booster shot.

The solution, available immediately to all large health plans, is meant to simplify care for patients with complex conditions.