In today’s ACT Brief, we examine how the FDA’s CNPV Program is reshaping operational planning and accelerated submission ...
FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21 SAVE Surveillance ...
Moderna recently faced pressure after the U.S. Food and Drug Administration announced plans to require more rigorous safety ...
FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.
Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by ...
The FDA has cleared Neurosense to begin its pivotal Phase 3 clinical trial of PrimeC for the treatment of amyotrophic lateral ...
The Global Oral Drug Delivery Market is poised for growth driven by technological advances in drug delivery systems, ...
European Union regulators have placed much heavier restrictions on common phthalates, because they damage the reproductive ...
Denali's validated platform, strategic pipeline, and experienced management present a compelling long-term investment ...
Detailed price information for Solid Biosciences Inc (SLDB-Q) from The Globe and Mail including charting and trades.
As 2026 approaches, rising complexity, geopolitical pressures and new modalities are reshaping strategy, capacity and CDMO ...
Emily Standley Allard on MSN
Why It's Hard for Foreign Biotech Companies to Hire in the US
This article is for CEOs, investors, and HR folks outside the US who want to get into or grow in the US biotech world. We'll ...
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