Browsing Tag
FDA approval
131 posts
Artivion (NYSE: AORT) begins pivotal Arcevo LSA trial: Could this hybrid stent unlock an $80m U.S. market?
Artivion begins pivotal ARTIZEN trial with first patient treated using Arcevo LSA. Find out how this hybrid stent could transform aortic arch surgery.
FDA approves JNJ’s CAPLYTA for depression: Is this a new hope for MDD remission?
Johnson & Johnson secures FDA approval for CAPLYTA in major depressive disorder. Find out how this expands safe treatment options for difficult-to-treat depression.
FDA approves GSK’s Blenrep for myeloma—what sets it apart from CAR-T options?
GSK’s Blenrep approved by the FDA for relapsed multiple myeloma after Phase III trial success. Learn what this means for U.S. patients and global expansion.
SetPoint Medical to present new 12-month rheumatoid arthritis data at ACR 2025 ahead of U.S. launch
SetPoint Medical will present long-term RA trial data at ACR 2025, strengthening its FDA-cleared implant’s case ahead of commercial rollout. Learn more.
Tezspire gains FDA approval for CRSwNP, expanding AstraZeneca and Amgen’s reach in inflammatory airway diseases
Tezspire gets FDA approval for chronic rhinosinusitis with nasal polyps. See how AstraZeneca and Amgen are expanding the respiratory biologics frontier.
Hypertension breakthrough: Scienture launches first FDA-approved liquid losartan Arbli through U.S. distributors
Discover how Scienture’s Arbli is redefining hypertension treatment as the first FDA-approved liquid losartan and what it signals for SCNX investors.
Can AbbVie’s RINVOQ fill the biologics gap for IBD patients unsuitable for TNF therapy?
AbbVie gets FDA approval for broader RINVOQ use in IBD patients beyond TNF blockers. Find out how this impacts stock sentiment and investor expectations.
UZEDY wins FDA nod for Bipolar I maintenance therapy, boosting Teva and Medincell’s psychiatric drug portfolio
FDA expands UZEDY approval to Bipolar I maintenance therapy — explore how Teva and Medincell’s long-acting risperidone strategy is reshaping psychiatric care.
FDA approves Ligand Partner SQ Innovation’s Lasix ONYU for heart failure edema—at-home use marks major shift in care
Find out how Ligand and SQ Innovation’s FDA-approved Lasix ONYU is redefining heart-failure treatment with the first at-home edema therapy.
Crinetics Pharmaceuticals shares soar after FDA clears Palsonify, the first oral acromegaly treatment
Crinetics shares surged after FDA approval of Palsonify, the first oral acromegaly therapy. Learn how this launch reshapes patient care and investor sentiment.