News

Experimental drug NU-9 shows promise for Alzheimer's and ALS treatment
Experimental drug NU-9 - a small molecule compound approved by the U.S. Food and Drug Administration (FDA ... "They collect junk and other components that are not useful to the cell, chew them up and ...
Alston & Bird Allege Big Pharma Company Amgen Monopolized US Arthritis Drug Market
Alston & Bird allege their client has suffered more than $1 billion in lost sales from being unable to manufacture a ...
Food Safety News6d
Researchers say business user fees could ease budget woes at FDA and enhance food safety
A research team at New York University has come up with a way to fund FDA food programs, including food safety, without using ...
Food Safety News26d
FDA puts food safety rule on hold
In an announcement on March 20, the Food and Drug Administration said it intends to publish a proposed rule “at a later time.” The rule has already been published and approved and was set to ...
Palvella Therapeutics to Present at the Jones Healthcare and Technology Innovation Conference
A live webcast of the fireside chat will be available on the Events and Presentations section of Palvella's website at www.palvellatx.com. An archived replay of the webcast will be available for ...
News Medical29d
FDA-approved drug for chronic kidney disease may help mitigate antibiotic resistance
The team found that the U.S. Food and Drug Administration (FDA)-approved drug sevelamer ... "If you can inactivate antibiotics where they are not needed, you eliminate the driver of antibiotic ...
Kura Oncology and Kyowa Kirin Announce Submission of New Drug Application for Ziftomenib to FDA
Ziftomenib has received Breakthrough Therapy, Fast Track, and Orphan Drug Designations. The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review; Kura ...
Roll Call19d
Targeting FDA user fees would leave agency gutted, experts say
Kennedy Jr. and his allies rallied around removing industry influence from the Food and Drug Administration as ... time new pharmaceuticals were getting approved in the United Kingdom compared ...
USA Today19d
Viagra was approved by the FDA 27 years ago. It changed how we talk about sex.
Thursday marks 27 years since the U.S. Food and Drug Administration approved the sale of Viagra ... reframing sexual dysfunction not as a personal or psychological failing but as a legitimate ...
STAT6d
Why the closure of an FDA office may impact generics manufacturers — and everyday Americans
The Division of Policy Development in the Office of Generic Drug Policy, which was created more than a decade ago, was ...
Newsday25d
Why cheaper alternatives to weight-loss drugs like Wegovy, Zepbound will be tougher to get
But the Food and Drug Administration is phasing in bans ... Unlike the name brands, compounded versions are not FDA-approved. After the FDA declared shortages of the drugs over, for tirzepatide ...
AI in Software as Medical Devices (SaMD): Navigating Patent and Regulatory Challenges in the US, Europe
The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...