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 complex generic market needs to “achieve parity” with the innovator market, as the number of approvals is lagging the innovator sector and has not achieved its full market potential, said Robert ...

Trelegy Ellipta is a maintenance treatment for patients with asthma and COPD. "The FDA's acceptance of our ANDA filing for ...

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 ...

Complex generics are driving Indian pharma’s high-margin future in 2026: Experts: Shardul Nautiyal, Mumbai Friday, May 15, 2026, 08:00 Hrs [IST] Indian pharmaceutical companies, ...

Apotex, in collaboration with Orbicular Pharmaceutical Technologies Pvt. Ltd. and Gland Pharma Limited, today announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated ...

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 ...

Gottlieb is a senior fellow at the American Enterprise Institute and served as commissioner of the Food and Drug Administration from 2017 to 2019. President Trump often touted during his first term ...

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 ...