News

A Promising New AIDS Drug Highlights The Dangers Of Price Controls
The fact that lenacapavir will soon be available to patients is a testament to the strength of America's biopharmaceutical ...
STAT19h
Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
US FDA approves KalVista's oral swelling disorder drug, shares rise
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, the first on-demand oral ...
After delay, Kalvista wins FDA OK for drug to treat rare swelling disorder
The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an ...
Kennedy’s Battle Against Food Dyes Hits a Roadblock: M&M’s
The health secretary has used peer pressure to persuade food makers to nix synthetic dyes. The candy industry is holding out, ...
Food Dyes Are Lurking in Surprising Places
In addition to finding these dyes in brightly colored processed foods, the researchers also found them in more muted foods ...
Business Wire23h
KalVista Pharmaceuticals Announces FDA Approval of EKTERLY® (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has approved EKTERLY® (sebetralstat), a novel ...
ALS News Today21h
FDA grants orphan drug status to ALS gene therapy SNUG01
The FDA granted orphan drug designation to Sineugene Therapeutics' SNUG01, a first-in-class experimental gene therapy for ...
Publix Food Recall Update as 'Foreign Material' Found in Multiple Products
Publix has had to manage several recalls involving both meat and non-meat products since the start of the year.
Mustang Bio Shares Jump After Orphan Drug Designation for Cancer Treatment
Mustang Bio shares more than quadrupled, to $5.23, after the company on Monday said the Food and Drug Administration granted orphan drug designation to Mustang for MB-101 for the treatment of ...
Mustang Bio Granted Orphan Drug Designation by U.S. FDA for MB-101 (IL13Ra2-targeted CAR T-cells) to Treat Astrocytomas and Glioblastoma
In an ongoing Phase 1 trial published in Nature Medicine, MB-101 was well-tolerated and 50% of patients achieved stable ...
'Gas station heroin': The drug sold as a dietary supplement that's linked to overdoses and deaths
The US Food and Drug Administration (FDA) has issued an urgent warning about tianeptine—a substance marketed as a dietary ...