Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

The mind-expanding drugs may help heal many mental health conditions. But studies haven’t actually proved that yet.

The FDA's 'Elsa' AI, intended to speed up drug approvals, is reportedly fabricating studies, part of a wider trend of ...

The US Food and Drug Administration (FDA) has instructed all GLP-1 drug-makers to update their warning labels to include the ...

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

The FDA has decided not to approve vusolimogene oderparepvec (RP1) in combination with nivolumab for advanced melanoma.

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...

The FDA has begun accepting applications for a priority pathway designed to slas | The FDA has begun accepting applications for a priority pathway designed to slash review times to one to two months, ...

The FDA has decided not to approve glofitamab plus gemcitabine and oxaliplatin to treat certain patients with relapsed/refractory DLBCL.