SPOTLIGHT -
FDA clears first-in-class high cholesterol drug
Treatment is first non-statin LDL-C lowering treatment approved in years.
Pharma maker pulls weight loss drug over FDA concerns
Eisai disagrees with FDA decision.
FDA switches 3 drugs from prescription to OTC use
Treatments include meds for arthritis pain and allergy eye drops.
Lung cancer drug snags priority review
Treatment will be first to target a specific type of advanced lung cancer.
FDA clears novel generic thyroid cancer treatment
FDA cleared the first generic sodium iodide product to treat hyperthyroidism and carcinoma of the thyroid.
Small molecular drugs led 2019 approvals
FDA's Center for Drug Evaluation and Research approved fewer new treatments in 2019.
FDA clears landmark peanut allergy drug Palforzia
Global market for peanut allergy treatments estimate at $4.5 billion.
Top 3 drugs expected in first half 2020
A new class of drugs for high cholesterol and a novel peanut allergy treatment lead expected approvals.
Sarcoma med will be available soon
Novel cancer drug snags FDA approval.
MDMA could be approved to treat PTSD
Traditional party drug known as ecstasy is undergoing clinical trials to assist in PTSD treatment.
Epilepsy, bipolar drug recalled due to contamination
Lamotrigine was contaminated with a heart drug.
Blockbuster diabetes drug snags new heart indication
Ozempic’s approval follows Jardiance’s expanded heart indication last July.
FDA okays novel med for children with diabetes
Already approved for adult patients, Fiasp is now available for children.
More Ranitidine recalled, plus another big drug recall
Major depression drug recalled over wrong dosage.
Pfizer slashes prices as most pharma makers hike prices in new year
Pfizer bucks the trend with as high as 98.5% price cuts.
FDA clears first-in-class migraine drug
Approval of Ubrelvy follows several new migraine drugs.
Express Scripts reveals Digital Health Formulary coverage
Diabetes and hypertension are among the primary diseases included.
FDA okays new indication for fish oil drug
The fish oil drug is approved to reduce cardiovascular risk.
FDA warns maker of opioid dependence treatment
Alkermes omitted warnings about serious risks from taking the drug.
Health groups praise new FDA commissioner
Stephen Hahn is confirmed by the U.S. Senate.
New CMS rule will confuse patients, groups say
Hospitals sue over drug price disclosure rule.
FDA clears generic MS treatments
This is the agency’s first generic approvals of Gilenya.
FDA approves new indication for leukemia drug
Approval made via international collaborative effort.
Pharma makers, distributors face painkiller investigation
Federal subpoenas are latest in opioid actions.
FDA says CBD not recognized as safe in food, warns manufacturers
FDA cites 15 companies making unsubstantiated health claims.
Physicians’ group wants PBM drug price transparency
PBM mergers contribute to pricing problems, ACP says.
Experts debate drug prices, legislation
Trump claims lower drug prices, fights Pelosi bill.
Congress, FDA working to reduce drug shortages
FDA and Congress are putting forth new proposals to mitigate drug shortages, which continue to have a major impact on the US healthcare system.
Biosimilars poised to profit in lucrative retinal diseases market
Pharma maker develops biosimilars to Lucentis, Eyelea.
New biosimilar to blockbuster Neulasta available soon
Sandoz now has 2 biosimilars to the popular cancer drug.