FDA Approvals

The US handed Novavax a $1.6 billion funding 4 months into the pandemic, in July 2020, to speed the biotech's research of a coronavirus...

FDA Rebukes Althera On Cholesterol Medication Assertions

FDA Approvals

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

FDA Approvals

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

FDA Approvals

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

FDA Approvals

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

FDA Approvals

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

FDA Approvals

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...

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