Two institutional buyers of Gleevec want to stop its manufacturer, Novartis, from delaying generic competition of the blockbuster leukemia drug, saying a patent litigation settlement between the brandmaker and generics maker Sun Pharma ...
The U.S. Food and Drug Administration today announced its intention to take enforcement action...
Sponsors considering whether to use an adaptive clinical trial design should select a number of...
The Drug Supply Chain Security Act (DSCSA) requires dispensers, which primarily include...
Aimmune Therapeutics has won FDA breakthrough therapy designation for AR101, an oral immunotherapy for children and adolescents with peanut allergies. The designation, which entitles the company to more frequent meetings with the FDA ...
PhRMA and the Medical Information Working Group want the FDA to clarify its rules around manufacturer promotion of off-label drug use and are using a small drugmaker’s lawsuit against the agency to press their case.
A U.S. Supreme Court ruling last week that patents should be presumed valid could make it easier for medical devicemakers to sue for patent infringement, a patent law attorney said. The 6-2 ruling, with one abstention ...
Recent decisions by an FDA advisory committee in favor of approving two new cholesterol-lowering drugs will set up another chapter in the ongoing value debate between drugmakers and health insurers, according to Fitch Ratings.
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines....
Devicemakers won’t have to stage new clinical trials of their devices to gain approval in China if they can demonstrate that they’re basically equivalent to devices already on the market, Chinese regulators say.
The AIDS industry and its government allies were just waiting for evidence to justify a change in policy.
Dougherty County District Attorney Greg Edwards dismissed a malice murder charge against 23-year-old Kenlissia Jones, who spent about three days in jail after seeking help at a hospital.
Federal health advisers recommended approval for a highly anticipated cholesterol drug from Sanofi and Regeneron Pharmaceuticals, but with the caveat that more data is needed about its long-term ability to reduce heart attacks.
RecAP is currently in Phase II development for testing the potential treatment of acute kidney injury, with the potential to be developed for hypophosphatasia.
Georgia prison officials pointed to cold storage temperatures as "the most likely cause" of the cloudiness in a lethal injection drug that halted an execution — but testing may indicate otherwise.
Gabe Griffin lobbied his first bill at the age of 9. It became law when he turned 10. He'll be in a wheelchair when he turns 12. Without the right drugs, his parents say he'll be dead in a decade.
Federal health regulators said Friday that a highly-anticipated, experimental drug from Sanofi lowers bad cholesterol more than older drugs. But officials have additional questions regarding study results.
U.S. Food and Drug Administration investigators determined the bottle contained 10 fish oil capsules, 70 phenytoin capsules and several stool softener pills.
Thursday's suspension leaves about 250 people in 46 NIH studies waiting to hear when they will receive other experimental treatments.
A California woman last month sued her insurance provider over a drug to treat hepatitis C, the latest episode involving the skyrocketing costs of specialty medications.
A $6 million gift from Janssen Pharmaceuticals will help spur Rutgers’ research into “revolutionary” continuous manufacturing.
Meet Katherine Campbell — a woman testifying at an FDA meeting this week in hopes of seeing a female libido drug getting approved.
The U.S. has a drug shortage problem that refuses to go away. Here's a look at what it means for manufacturers, patients and doctors.
Lannett Company announced that it has completed the acquisition of privately held Silarx Pharmaceuticals - a manufacturer and marketer of liquid generic pharmaceutical products.
Senior leaders announced plans to file for regulatory approval of more than 10 new products between 2015 and 2019.
The makers of a pill intended to boost sexual desire in women will try again this week to persuade regulators that the drug warrants approval after two rejections.
Contamination problems and the high cost of regulations have caused manufacturing delays and drug shortages that are only getting worse.
Two prominent lawmakers are following through on a promise to do something about recent rises in generic drug prices, with identical House and Senate bills that would force generic drugmakers to pay ...
The FDA's recent approval of Zarxio, the first biosimilar product approved in the United States, points toward growth in the contract manufacturing marketplace, according to Kalorama Information.
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