manilatimes5h
Tempest Reports Third Quarter 2024 Financial Results and Provides Business Update
Received a "Study May Proceed” letter from the U.S. Food and Drug Administration (FDA ... 3 trial for the first-line ...
manilatimes6h
Journey Medical Corporation Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights
Journey Medical Corporation (Nasdaq: DERM) ("Journey Medical” or "the Company”, "we”, or "our”), a commercial-stage ...
STAT9h
FDA commissioner suggests RFK Jr. and Trump might compromise an agency ‘at peak performance’
The agency’s ability to hire and retain skilled employees may be in jeopardy given Trump ally Robert F. Kennedy Jr.’s ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
BioPharma Dive10h
Biotech investors, including Third Rock, pump $100M into a startup’s genetic medicine for ALS
Trace Neuroscience aims to advance an RNA-binding therapy designed to preserve — and potentially improve — muscle function in ...
Intercept Receives Complete Response Letter from FDA Addressing OCALIVA supplemental New Drug Application (sNDA)
The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...