Agri-Pulse8d
Food system stakeholders push FDA for delayed, staggered traceability timeline
Food safety stakeholders continue to warn the Food and Drug Administration that much of the supply chain is not ready to ...
BioSpace4d
5 Late-Stage mRNA Vaccines to Watch
The potential of mRNA vaccines was established during the COVID-19 pandemic. Now, a new wave of candidates could soon hit the ...
Applied Therapeutics: Pushing Towards FDA Approval
Applied Therapeutics, Inc. is nearing FDA approval and potentially gaining another approval in 2025 for a different ...
Moderna forecasts lower sales next year, shares near four-year low
Its cost savings would include a cut of $1.1 billion from research and development from 2026, with most of the actions in ...
RTE Online7d
Shares of vacine maker Moderna slide to four-year low
Moderna pushed its break-even goal by two years as it delayed the timeline for developing several key products and predicted ...
Iterum Therapeutics Provides Update on FDA Advisory Committee Discussion of Oral Sulopenem for the Treatment of uUTI in Adult Women
FDA Decision Expected by PDUFA Goal Date of October 25, 2024Potential to be First Oral Penem Approved in the U.S.DUBLIN and CHICAGO, Sept. 10, ...
Business Insider4d
Zentalis Pharmaceuticals Announces FDA Has Lifted Partial Clinical Hold on Azenosertib Studies
The FDA has cleared the Company to resume enrollment ... to azenosertib clinical development and other data presentation timelines. The Company remains on track to meet all previously disclosed ...
STAT23d
Medicare’s new transitional coverage of emerging technologies program doesn’t go far enough
As a result, many new products, though approved by the FDA, would not meet Medicare ... includes some procedural changes that may shorten timelines for Medicare decision-making, allow for ...