News

Capricor: Maintaining Hold Rating In Light Of Deramiocel Complete Response Letter
Capricor Therapeutics is expected to release data from the phase 3 HOPE-3 trial in Q3'25, thus presenting a potential path ...
Ritz peanut butter crackers recalled over labeling mistake
A labeling mistake has led to a nationwide recall of four different types of Ritz peanut butter cracker sandwich cartons, ...
Precision Medicine Online1d
Eli Lilly's Kisunla Gets New Dosing Schedule in FDA-Approved Labeling Update
The new dosing schedule with a more gradual titration significantly lowered incidence of ARIA-E in the TRAILBLAZER-ALZ 6 trial.
BioSpace1d
FDA Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
KFF Health News1d
FDA Posts 200 Letters Citing Initial Concerns About Approved Drugs
The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency's initial feedback or requirements for more data. These ...
15 alternatives to Ozempic for weight loss
Ozempic is an FDA-approved medication for people who have type 2 diabetes. It’s often prescribed “off-label” for weight loss ...
The Royal Gazette1d
Jury in drug-trafficking trial shown ‘bricks of cannabis’
A Supreme Court jury was shown six “bricks” of a compressed plantlike material during the trial yesterday of a man charged ...
EURweb1d
Ritz Peanut Butter Cracker Recall Issued Due to Mislabeled Cheese Packs
Mondelēz Global LLC recalls Ritz Peanut Butter Cracker Sandwiches due to mislabeling as cheese, posing risks for peanut allergy sufferers.
Bloomberg on MSN1d
FDA to Revisit Opioid Labeling for Chronic Pain
FDA Commissioner Dr. Marty Makary says the agency will revisit the labeling system for OxyContin and similar drugs, saying ...
Neurology Advisor2d
FDA Approves New Dosing Regimen for Kisunla in Alzheimer Disease
The FDA has updated the labeling for Kisunla™ (donanemab-azbt) to include a new recommended titration dosing schedule for adults with early symptomatic Alzheimer disease.
Ultragenyx: 'Hold' The Best Strategy As Stock Tanks On Bone Disease Study Miss
Ultragenyx Pharmaceutical Inc. shares plunged 30% as UX143 trial raises efficacy doubts. Click for more on RARE and my ...
Becker's Hospital Review2d
FDA OKs label change for Alzheimer’s drug
The FDA has approved a label update for Eli Lilly’s Kisunla, an Alzheimer’s treatment, by modifying the recommended dosing schedule for adults with early symptomatic Alzheimer’s disease. The update ...