Legal News

RizaFilm is a different formulation of rizatriptan that has been changed into a film, meant to be taken orally and absorbed in mouth.

This comes after a district court in Texas ruled to keep Mifepristone available, but with heavy restrictions.

Proposed legislation would cap the price of insulin at $35 for a 30-day supply.

GrayMatters Health plans to use its technology for other mental health indications in the future.

The FDA granted the EUA based on the phase 3 trial results that demonstrated vilobelimab's efficacy compared to placebo, with a 23.9% relative reduction in all-cause mortality from COVID-19 at 28 days.

The FDA, state governors, and OB/GYN groups around the country are fighting back against Judge Matthew Kacsmaryk’s ruling.

The drug, called Atovaquone, has been voluntarily recalled due to possible Bacillus cereus contamination.

Data suggest confirmatory trials conducted for drugs granted accelerated approval by the FDA have taken over 3 years on average to complete since 2012.

The biopharmaceutical company says it is “extremely disappointed” with the results of the COURAGE-ALS study, which failed to meet primary or secondary endpoints.

The ruling states that insurers and employers who run plans for employees will have a choice over how- and whether- to cover certain routine screenings, exams and tests.

The drug is a rare FDA-approved liquid formulation that treats ulcers and lowers risk of gastrointestinal bleeding in chronically ill patients.

The AVMA is working with lawmakers to help increase the numbers of animal drug approvals.

The drug, called Tauramox, is the first generic moxidectin injectable solution to control internal and external parasites.

The suit alleges that Express Scripts, Prime and Prime customer Humana Pharmacy Solutions are able to share drug pricing and rebate information to increase prices for insulins, biologics and cancer drugs.

If approved, Perrigo’s Opill would be the first nonprescription birth control pill ever.

Sponsored by Provetica, Modulis for Cats contains the same active ingredient, concentration and dosage form as the Atopica for Cats brand product.

Though unlikely to pass this year, opponents say the proposal is nonetheless amplifying the spread of false claims and sowing distrust of medical professionals.

The drug, branded as Rezzayo, is the first FDA-approved invasive candidiasis treatment in over a decade.

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.