Browsing Tag
FDA approval
131 posts
GSK wins FDA approval to extend Arexvy RSV vaccine to at-risk adults aged 18 to 49, opening 21 million-strong US market
FDA expands Arexvy approval to at-risk adults 18-49, opening 21M-strong US market. Read what this means for GSK, Pfizer, Moderna, and the RSV vaccine landscape.
Rubraca beats docetaxel in TRITON3: FDA clears early-line prostate cancer use for Tolmar
Tolmar’s Rubraca gains FDA approval for BRCA-mutated prostate cancer before chemotherapy. Explore the trial results and what it means for treatment strategy.
How Hansa Biopharma’s imlifidase could redefine access for hardest-to-match transplant candidates
Hansa Biopharma seeks FDA approval for imlifidase to expand transplant eligibility in high-risk ESRD patients. See what this filing means for U.S. access.
Can GSK’s Exdensur transform asthma biologics with just two doses per year?
GSK’s Exdensur is now FDA approved as the first biannual biologic for severe asthma. Explore what this means for rivals, payers, and global strategy.
From tissue to biologic: AVANCE’s FDA clearance marks a turning point for nerve injury treatment
Axogen gets FDA biologics nod for AVANCE nerve graft, unlocking 12 years of exclusivity. Find out how this reshapes nerve repair in 2026 and beyond.
Vanda Pharmaceuticals (NASDAQ: VNDA) gains after FDA sets new December 5 date for tradipitant re-review
Vanda Pharmaceuticals moves closer to FDA approval for tradipitant in motion sickness while targeting the GLP-1 side effect market. Find out what’s next.
Alkermes raises Avadel bid to $2.37bn with enhanced CVR terms tied to LUMRYZ FDA milestone
Alkermes raises Avadel bid to $2.37B with improved CVR linked to FDA approval for LUMRYZ in idiopathic hypersomnia. Read the full transaction breakdown.
How Arrowhead Pharmaceuticals’ first FDA-approved drug Redemplo could reshape treatment for familial chylomicronemia syndrome
Discover how Arrowhead Pharmaceuticals’ FDA approval for Redemplo could transform care for familial chylomicronemia syndrome.
Can Allurion Technologies reset investor confidence with FDA momentum and a debt-free strategy?
Allurion Technologies aims to bounce back with FDA milestones, a debt-free strategy, and new capital. Will this turnaround move the stock in 2025?
FDA gives CAPLYTA the go-ahead for major depressive disorder, boosting hopes for better remission rates
Find out how CAPLYTA’s FDA approval for major depressive disorder could redefine depression treatment and improve remission outcomes.