The Latest Breaking News from FDA

Montana's New Rules Let Licensed Clinics Sell Drugs That Cleared Only Phase 1 Safety Testing to Paying Patients

Montana now lets licensed clinics offer drugs that have passed only Phase 1 trials. Here is what that testing does and does not prove for patients.

Medical Daily · Sep 18

All Impella Heart Pump Controllers Face Global Repair After Part Failures Tied to Three Deaths and 37 Injuries

Abiomed is removing all Automated Impella Controllers for part replacement after failures tied to three deaths. Here is what families should know.

Medical Daily · Sep 18

Hospital Antibiotic Cefepime Tied to Small Possible Rise in 30-Day Deaths in Review of 110 Trials

A review of 110 trials links cefepime to a small possible rise in 30-day deaths. Here is what the 94% figure means and what families can ask.

Medical Daily · Sep 18

Neuroendocrine Tumor Patients Gain a Second Lutetium Dotatate Option as FDA Approves Curium's Bexlutry Radioligand Injection

The FDA approved Curium's Bexlutry, a second lutetium Lu 177 dotatate therapy for adults with SSTR-positive GEP-NETs. Here is what it means for access.

Medical Daily · Sep 17

Pancreatic Cancer Pill Daraxonrasib Gets FDA Breakthrough Status for Untreated Metastatic Disease When Paired with Standard Chemotherapy

The FDA gave daraxonrasib breakthrough status with gemcitabine and nab-paclitaxel for untreated metastatic pancreatic cancer. The combination is not yet approved.

Medical Daily · Sep 17

Third Texas Pharmacy Recalls Injectable Glutathione and Myer's Cocktail Vials Shipped to Homes Nationwide Over Endotoxin

Centric Compounding recalled six lots of glutathione, Myer's Cocktail, and Tri-Immune Boost vials sent to homes and prescribers nationwide. Check lots and symptoms.

Medical Daily · Sep 17

So Delicious Dairy-Free Frozen Dessert Recalled Nationwide Over Possible Small Stones

Check your freezer if you recently purchased So Delicious Dairy Free Salted Caramel Cluster frozen dessert. Danone USA has issued a nationwide voluntary recall of certain pints because cashew pieces in the product may contain small stones or other hard foreign material.

Grocery Coupon Guide · Sep 17

Drugmakers and Research Partners Have Until October 30 to Apply for FDA Pilot Targeting First Human Trials

The FDA finalized its Expedited IND Pilot and is taking applications through Oct. 30. What changed, what an IND is, and why approvals are not faster.

Medical Daily · Sep 17

IgA Nephropathy Patients on Trutakna Kept Kidney Function Nearly Steady for Two Years While Placebo Group Declined

Two-year ORIGIN 3 data show Trutakna held kidney function nearly steady in IgA nephropathy. What it means for patients, coverage, and approval.

Medical Daily · Sep 17

Ivonescimab Topped Keytruda on Median Lung Cancer Survival by Eight Months in China but Lacks U.S. Approval

Ivonescimab beat Keytruda on survival in a China-only lung cancer trial, but the drug is not approved in the U.S. Here is what patients should know.

Medical Daily · Sep 17