News

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 ...
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 ...
US FDA approves KalVista Pharma's 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 ...
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 ...
STAT2h
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 ...
ALS News Today3h
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 ...
Oregon Infants Sickened By Lead in Recalled Target Baby Food
MONDAY, July 7, 2025 — Two babies in Oregon got sick with lead poisoning after eating baby food from Target that was ...
Clinical Trials Arena5h
FDA and EMA authorise AB Science’s Phase III trial of prostate cancer treatment
The FDA and the EMA have authorised AB Science’s confirmatory Phase III Study AB22007 trial of masitinib for mCRPC.
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 ...
FMIBlog9h
Global Surge in Medical Foods Exposes Regulatory and Healthcare Gaps
The global medical foods market is on a breath taking ascent, underpinned by rising chronic disease rates, growing geriatric ...
US FDA approves KalVista Pharma's swelling disorder drug
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug for a type of hereditary swelling disorder, sending its shares up 33.3% in premarket trading.
Clinical Trials Arena on MSN2d
Vertex reports long-term results for Casgevy in sickle cell and thalassaemia
Across 100 patients in three Phase III studies, Vertex's Casgevy showed lasting benefits for more than five years.