It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...

Happy Friday. Today, we talk about the stem cell fire sale at CIRM, and about the FDA’s move to release a limited batch of ...

HealthDay News — The US Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted ...

The U.S. Food and Drug Administration declined to approve Capricor Therapeutics' cell therapy for a heart condition and asked for more data, the drugmaker said on Friday, sending its shares 40% lower ...

The FDA told Capricor in a letter that it is unable to approve its application for Deramiocel in its current form as it does ...

Supplements are part of the daily routine for over half of adults in the United States. However, they aren't regulated in the same way that medications are, so it’s important to be aware of possible ...

Gland Pharma’s Pashamylaram facility has received GMP compliance certification from the Danish Medicines Agency for ...

Women who might become pregnant should be especially cautious with vitamin A supplements or avoid them entirely .

We also found that tumors release a protein called Activin-A, which acts on blood vessels to cause the leakiness and, ultimately, loss of blood vessels in the muscle. When we used a gene therapy to ...

The $4 billion that the United States pledged for the global HIV response for 2025 disappeared virtually overnight in January ...

Note that some links may require registration or subscription. The FDA classified a nationwide recall of chocolate products ...

The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising questions about whether the agency's new leadership may be rowing back from ...