FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved'
Presbyopia, the age-related loss of near vision, could soon be treated successfully
Despite steep funding setbacks, the global HIV response has gained momentum in 2025 with the introduction of twice-yearly injectable LEN
Patients can now get the starting 2.5 mg dose for $299 per month
Under the proposed terms, Vaximm would secure a $20 million upfront payment, up to $815 million tied to clinical, regulatory, and commercial milestones
StarGuide GX delivers ultra-high sensitivity and high-resolution imaging, enabling fast, confident diagnostics
The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026
The oral, film-coated tablet is licensed for patients whose cancer has returned during or shortly after hormone therapy
Nitrosamines have prompted evolving global guidelines that demand rigorous industry oversight
Renalyx will continue operating as an independent unit within the group
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