Lower middle- and low-income countries are less likely to receive market authorization for drugs that were trialed within their state and approved by the FDA within 5 years of approval when compared ...
After a meeting with the FDA, Scholar Rock is planning a 2026 resubmission of its application seeking approval of apitegromab ...
Earlier this year, researchers at Children's Hospital of Philadelphia and Penn created a first-of-its-kind drug customized to ...
Last patient for the randomized double-blind portion completed the study; top-line results are expected by year-end. PALISADE ...
Insight Molecular Diagnostics Inc. is rated Hold due to upcoming catalysts & pending FDA submission for GraftAssureDx. Read ...
The Food and Drug Administration (FDA) has issued new draft guidance signaling a policy shift toward reducing the need for comparative efficacy ...
FDA approves multiple denosumab biosimilars, enhancing market access and introducing interchangeability, boosting competition in bone health therapies.
Trailing Twelve-Month Core Product Sales -- $37 million, a company record, up from $33.8 million, with distributor and ...
CRRT (Continuous Renal Replacement Therapy): A form of dialysis used for critically ill patients that continuously removes ...
Grail saw a sharp rise in third-quarter sales as it outlined a firmer FDA submission date for its Galleri cancer blood test. | Grail saw a sharp rise in third-quarter sales as it outlined a firmer FDA ...
Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
In a highly anticipated article, FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., outlined a novel regulatory ...
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