Berlin: Bayer has announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug ...

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration ...

The rapid emergence and re-emergence of viral pathogens—exemplified by outbreaks of influenza, Ebola, Zika, and, most recently, SARS-CoV-2—underscore the ...

A generic version of ibrutinib was granted tentative approval by the FDA for use in CLL and SLL with 17p deletion and ...

Bayer said the Food and Drug Administration extended the review period for its new drug application of elinzanetant, a treatment for moderate to severe vasomotor symptoms, also known as hot flashes, ...

A potential target for experimental drugs that block PRMT5—a naturally occurring enzyme some tumors rely more on for survival ...

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing ...

Researchers at the National University of Singapore (NUS) have found new applications of magnetic field therapy with ...

These updates support Ocugen in its efforts to pursue its goal of 3 biologics license applications (BLA) in the next 3 years.

The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment ...

"The reason we chose the technique that's being used is because it can be about as sensitive as a dog in detection," said ...