Browsing Tag
FDA
341 posts
Imlifidase clears pivotal US Phase 3 trial with strong kidney transplant results as Hansa Biopharma eyes FDA filing
Hansa Biopharma’s Imlifidase meets its Phase 3 trial endpoint in US kidney transplantation, setting up FDA filing and reshaping biotech investor sentiment.
Atai Life Sciences stock jumps 15% after Beckley Psytech trial update deepens investor interest in BPL-003
Atai Life Sciences stock surged 15% after positive BPL-003 trial data with Beckley Psytech. Investors eye Phase 3 momentum and merger milestones.
Zepbound vs Wegovy: How dosing, dual agonists, and payer dynamics are redrawing market lines
Zepbound and Wegovy are reshaping obesity drug competition—see how dosing, dual-agonist design, and payer rules define the next pharma showdown.
Can Merck’s new Keytruda injection delay biosimilar threats and change cancer care forever?
Find out how Merck’s newly FDA-approved Keytruda QLEX injectable version aims to improve cancer care with faster, more convenient treatment. Read on.
Medtronic stock dips even as FDA clears Altaviva device for bladder control breakthrough
Medtronic (NYSE: MDT) wins FDA approval for Altaviva, a minimally invasive bladder control device. Find out why the stock fell and what it means for investors.
Can high-dose GLP-1 therapies reshape obesity care—or are we nearing the biological ceiling?
Are high-dose GLP-1 drugs like Wegovy 7.2mg and Zepbound 15mg unlocking better weight loss—or just more side effects? Here’s what the latest data suggests.
Eisai’s etalanetug earns FDA Fast Track status, signaling new hope in Alzheimer’s therapy
Eisai’s etalanetug gets FDA Fast Track for Alzheimer’s, signaling a major shift toward tau-targeting therapies. Find out what this means for investors.
Novo Nordisk eyes FDA approval for high-dose 7.2mg Wegovy after STEP UP trial shows 21% weight loss
Novo Nordisk seeks U.S. approval for 7.2mg Wegovy after 21% average weight loss in trials. Can it outpace Eli Lilly’s Zepbound in the obesity drug race?
Krystal Biotech stock jumps after FDA expands Vyjuvek label to newborns and at-home use
Krystal Biotech stock surged after the FDA expanded Vyjuvek’s label to newborns and caregiver use, boosting adoption potential and investor confidence.
Pulnovo Medical secures dual IDE approvals with CMS backing to advance PADN clinical trials in the U.S.
Pulnovo Medical gains FDA IDE and CMS coverage to launch PADN U.S. trials, signaling disruption in the pulmonary hypertension device market.