The US Food and Drug Administration (FDA) needs to develop guidance on post-approval changes for complex generics, and to update its guidance on post-approval changes for non-complex generics as ...
The US Food and Drug Administration (FDA) just launched a new webpage to share recent actions and activities related to complex generic drugs to spur their development. “Since these products are ...
The MarketWatch News Department was not involved in the creation of this content. Partner Apotex Corp. (Apotex) to market and distribute to the U.S. healthcare market MIRAMAR, Fla., April 9, 2026 ...
WESTON, Fla., April 10, 2026 /PRNewswire/ - Apotex Corp. today announced it has received the first U.S. Food and Drug Administration (FDA) Tentative Approval for its Abbreviated New Drug Application ...
The medication is used to treat adults with certain lung diseases. This approval represents a significant advancement in DifGen's expanding portfolio of complex generics and underscores the company's ...
Generics may still account for the majority of U.S. prescriptions, but they no longer guarantee attractive economics. Aggressive competition and steady price declines have eroded profitability in ...
Amphastar has received permission from the Food and Drug Administration for iron sucrose injection, 50mg/2.5ml, 100mg/5ml and 200mg/10ml in single-dose vials, previously referred to as AMP-002. Iron ...
The Food and Drug Administration signed off on the first-ever weight-loss generic on Thursday, a knockoff of Novo Nordisk'sNVO Saxenda from Teva PharmaceuticalTEVA. Saxenda, the branded name for ...
Generic drugmakers continue to navigate a challenging U.S. market defined by persistent price erosion, intense competition and structurally thin margins. While demand for generics remains steady, ...
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