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 ...
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3 generic drug stocks to watch as new growth drivers emerge
Generic medicines remain one of the most important pillars of global healthcare, but the industry's growth drivers are ...
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 ...
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 ...
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 ...
Indian pharmaceutical companies are strategically increasing investments in the US market, focusing on specialty drugs, ...
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 ...
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