FDA accepts for review a Camurus NDA resubmission for Oclaiz (octreotide), a long-acting injection for treating acromegaly.
Bolton Medical recalls its Relay Pro Thoracic Stent Graft Systems due to reports of a deployment failure that may result in serious injury or death.
FDA releases the form FDA-483 with five observations from an inspection at Icelands Alvotech EF.
MassDevice reports a Minnesota federal judge gave significant victories to Medtronic and FDA in four cases involving the companys spinal cord stimulat...
FDA publishes the latest CDER guidance agenda showing plans for 85 new or revised guidances to be issued in 2026.
FDA approves Merck's Lipfendra (enlicitide) 20 mg tablets as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol in certain ...
Kalshi launches a pilot program allowing traders to buy and sell contracts tied to the outcomes of late-stage clinical trials and FDA regulatory decis...
FDA releases the form FDA-483 with 13 observations from an April inspection at Chinas Zhejiang Hushai Pharmaceutical Co.
