On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...

today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Fertilo, to enable the launch of the first US-based Phase 3 clinical ...

Gameto, a clinical-stage biotech company developing iPSC-based therapies for women’s health, today announced that the U.S.

These particles can originate from various sources such as the manufacturing equipment, packaging materials - like vials or stoppers - the environment, or even the drug ingredients themselves.

Little dark things shouldn’t be in vials of a drug, which is why one lot of an injection drug used to deal with low blood pressure under anesthesia got recalled. Provepharm said it pulled lot No.