Using the the 351 (K) and the 505 ((b)) (2) pathways, Pfenex (PFNX) develops biosimilars of major drugs that are going off-patent. It is currently developing biosims for 4 major drugs, Forteo, ...
Forteo (teriparatide) is a brand-name drug that doctors prescribe for some people with osteoporosis. It contains proteins that strengthen bones and stimulate new bone growth. A typical prescription is ...
In December 2025, Amphastar Pharmaceuticals announced that the FDA approved its abbreviated new drug application for a teriparatide injection prefilled pen, deemed bioequivalent and therapeutically ...
BEECH ISLAND, S.C.--(BUSINESS WIRE)--Ambio, Inc., an innovative biotech company developing novel peptide drugs, biosimilar, bioequivalent, and other complex generic drugs, announced today that a ...
RANCHO CUCAMONGA, CA / ACCESS Newswire / December 15, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's ...
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