We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Despite the COVID-19 pandemic making manufacturing site inspections difficult in 2020, the FDA’s Center for Drug Evaluation and Research (CDER) met most of its drug and biologic review goals last year, but — as it warned it would — the agency struggled to meet its inspection goals. Read More
The decision was based on positive results from two studies showing the drug provided a statistically significant improvement in progression-free survival. Read More
Merck said Tuesday its blockbuster cancer drug Keytruda (pembrolizumab) has received European Commission approval as a standalone therapy for two types of colorectal cancer. Read More
Gilead Sciences recently announced that it would no longer pursue FDA approval for Jyseleca and it downgraded a multibillion-dollar development pact with Galapagos. Read More
Cabenuva, the first long-acting injectable drug for HIV, has received FDA approval, providing the first-ever FDA-approved alternative to oral meds taken every day by those living with HIV. Read More
The CAR-T therapy uses the patient’s white blood cells as modified in a laboratory to attack cancer cells before being infused back into the patient. Read More