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Intercept’s failure to secure FDA approval for obeticholic acid (OCA) tablets in non-alcoholic steatohepatitis shines a light on safety challenges in the space, experts told BioSpace.
The company reported second-quarter revenue Wednesday that included $248.4 million of back royalties and associated interest related to the successful outcome of an arbitration case with J&J’s Janssen.
With partner Biogen mum on zuranolone’s prospects as an FDA August 5 review deadline approaches, Sage Therapeutics’ stock fell Wednesday to its lowest level in months.
On the heels of a European Union investigation, the UK’s health agency is reviewing safety data for GLP-1 receptor agonists after reports of self-harm and suicidal thoughts.
In a recent study of the U.S. states with the best and worst job markets, nine came out on top. Read on for details about the life sciences industry and jobs available in each state.
The Phase III trial, which will test the companies’ mRNA-based personalized cancer vaccine and Merck’s blockbuster Keytruda checkpoint inhibitor, is slated for completion by the fall of 2029.
While GlaxoSmithKline is anticipating a slower uptake of respiratory syncytial virus vaccine Arexvy, CEO Emma Walmsley said Wednesday the company is pinning much of its growth on the vaccine’s performance.
The Federal Trade Commission’s increased scrutiny of mergers has now hit IQVIA, whose proposed acquisition of Propel Media has been challenged by the watchdog agency.
Following several clinical failures for its candidates Roxadustat and pamrevlumab, FibroGen CEO Enrique Conterno is stepping down for “personal reasons,” the company announced Tuesday.
Embattled SQZ Biotechnologies announced Tuesday that the Swiss biotech will not exercise its option for HPV 16 positive solid tumors under the SQZ-APC-HPV program.
The biotech’s “Fit for Growth” program, which includes the headcount reduction, is expected to generate a net savings of $700 million on operating expenses by 2025.
While chemo drugs remain in shortage, Congress asks for answers from the FDA to find solutions to the supply chain disintegration.