The US Food and Drug Administration (FDA) on Wednesday revised its questions and answers guidance on generic drug development and abbreviated new drug application (ANDA) submissions during the ...

The applications address the same indications covered by the reference medicines, including Type-2 diabetes and weight management.

Huons Group is accelerating its focus on pharmaceuticals and bio-business through subsidiary restructuring and mergers and acquisitions (M&A). The company is overhauling its existing structure ...

Indian companies filed 184 Type II DMFs with the US FDA in Q1 2026 against China's 149, reinforcing the country's leadership ...

The US Food and Drug Administration (FDA) has published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and drug-device ...

Off-patent medicines provide people with access to high-quality essential treatment options that can be significantly less expensive than branded on-patent medicines. Off-patent therapies — generics ...

Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter ...

Bosutinib tablets (400mg) was a first-to-file product and is eligible for 180-days of generic drug exclusivity for this ...

Generic drug repurposing is an underused but promising tool for finding new, affordable therapies. Creating a pull incentive can spur developers to finally explore the untapped potential in these ...

Forbes contributors publish independent expert analyses and insights. Sally Pipes is a scholar and think tank CEO who writes on health care. America’s generic drug market is one of our greatest health ...