
The drug, called Leniolisib, is the first and only treatment approved in the United States for APDS, a rare primary immunodeficiency.

The drug, called Leniolisib, is the first and only treatment approved in the United States for APDS, a rare primary immunodeficiency.

The drug Leniolisib, now with the brand name Joenja, treats APDA, a genetic disorder that impairs the immune system. Its annual list price will be $547,500.

Regulatory officials said additional requirements are needed in order to approve the drug, which is under review for treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.


Evkeeza, which treats a rare form of high cholesterol, is now approved for patients as young of 5 years.

Stipulations of the settlements include data reporting, annual training, and an independent compliance officer.

Drug Topics will continue to update this story as new information becomes available.

Investigators set out to evaluate how medication access for certain rheumatic conditions has changed since June 2022.

Medicare users will see prescription drug pricing reform thanks to the Inflation Reduction Act.

A joint statement from the two Democrats senators says prescription drug reform would save the federal government $288 billion over the next 10 years.

The American Medical Association is urging the FDA to approve OTC access to oral contraceptives.

During COVID-19, pharmacy technicians helped keep immunization programs running.

The bill allows state attorneys general and the Federal Trade Commission the ability to initiate legal action against certain PBM business practices.

The administration also pledged to continue its work with existing pharmacy partners to improve the patient experience.


APhA priorities include pharmacist reimbursement, PBMs, and DIR fees.

Iowa Senator Chuck Grassley is pushing the FTC to investigate PBM practices.

NACDS CEO responds to comments by AMA president.

Without transparency, pharmacy owners must clear numerous hurdles to run an effective business.

Many will be forced to forgo care or return to the workforce to pay health care bills

Does anxiety justify an exemption from vaccine mandates among health care workers?

Robert M. Califf, MD, MACC, was approved in a 50-46 vote by the senate.

Drug overdoses now cost the United States about $1 trillion annually.

CMS and state officials are using payment incentives, data collection and program requirements to start edging the lofty ideals of health equity toward reality.

Employee mandate would have impacted 84 million workers. Healthcare mandate affects every facility that receives federal funding.

The findings show that increased access to emergency contraception does not compromise use of other more effective methods or lead to an increase in reported levels of unprotected sexual intercourse, according to Hawkins.

Free coverage starts January 15

The NCPA urges pharmacists to send an electronic message to Governor Kathy Hochul to sign 3 pro-pharmacy bills that are currently waiting her signature.

Take a look back at the top 10 legal news articles published on Drug Topics® this year.