FDA Rebukes Althera On Cholesterol Medication Assertions
Althera Pharmaceuticals, a producer of cardiovascular drugs, is being investigated by the FDA for its cholesterol oral delivery medicine, Roszet. The FDA's Office of...
Rejected By The FDA, NICE Endorses The Anaemia Drug Evrenzo
Despite a high-profile FDA denial, FibroGen and its collaborators have been able to expand into new markets outside of the United States with Evrenzo,...
Bluebird Gene Therapy Given FDA Nod Despite Safety Issues
Bluebird bio has persuaded an expert committee that the benefits of its gene therapy possibility, eli-cel, exceed the risks, at least in certain patients,...
USFDA Warns of Heart Irritation After Novavax COVID Vaccine
Even though the company's analysis found it could reduce the likelihood of mild-to-severe disease, the US Food and Drug Administration has expressed concern about...
FDA Grants Novartis Cell Therapy For Follicular Lymphoma
The US Food and Drug Administration (FDA) has granted Novartis expedited approval for its CAR-T cell therapy Kymriah (tisagenlecleucel) to treat people with relapsed...
Diabetes Drug By Eli Lilly Has Been Approved By The FDA
With high hopes, Eli Lilly's Mounjaro (tirzepatide) was promoted to the big leagues in the week ending May 14, when the FDA approved the...
FDA Regulates Use of J&J COVID Jab Due To Risk Of Thrombosis
The US Food and Drug Administration recently announced that the Johnson & Johnson/Janssen COVID-19 vaccine's urgent use permit will be restricted to people 18...
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The Future of Digital Health
The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution....
Five Best Practices to Deliver Exceptional Multichannel Experiences
A one-size-fits-all customer journey no longer works. In the age of the consumer, the quality of the interaction is paramount. In this paper, we...
The Impact and Use of Social Media in Pharmacovigilance
Social media presents new channels and methods for biopharmaceutical companies to move away from traditional pharmacovigilance (PV) systems and safety reporting methods towards more...