The US Food and Drug Administration (FDA) has finalized guidance for industry on the pathway for discussions about complex products. The final guidance leaves largely untouched a 2017 draft guidance ...
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. WESTON, Fla., April 10, 2026 /PRNewswire/ - Apotex Corp. today announced it has received the first U.S. Food and Drug ...
EpiPen will face competition in a generic version of the auto-injector marketed by Teva Pharmaceuticals and approved by the U.S. Food and Drug Administration on Thursday. The FDA previously approved ...
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 ...
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 ...
The U.S. Food and Drug Administration on Tuesday approved the first generic Symbicort drug used to treat asthma and chronic obstructive pulmonary disease (COPD), which are two common pulmonary health ...
Craig Bleifer, Kevin Madagan, Jessica Vaughn, Ph.D. The U.S. Food and Drug Administration’s fiscal year 2027 budget justification includes more than 20 legislative proposals spanning drug and biologic ...
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 ...
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