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FDA approves new Amneal iohexol injection strengths for imaging use

Fri, 17 Jul 2026 08:00:11 -0400

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) announced it has received U.S. Food and Drug Administration approval for additional strengths and vial presentations of iohexol injection, according to a company press release.

The newly approved presentations include iohexol injection 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials, as well as 300 mg iodine/mL in a 50 mL vial. Amneal plans to launch these products in the third quarter of 2026.

The approvals complement the company's previously approved and launched iohexol injection 300 mg iodine/mL in 100 mL vials. Amneal claims these are the first generic versions referencing Omnipaque across the

Amneal Expands Iohexol Injection Portfolio with U.S. FDA Approval of Additional Strengths and Presentations

Fri, 17 Jul 2026 08:00:00 -0400

Approval of iohexol injection 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials, and 300 mg iodine/mL in 50 mL vial, significantly expands Amneal’s injectable contrast portfolio
Portfolio now positioned to address the majority of U.S. iohexol injection market demand across key presentations
Demonstrates Amneal’s continued leadership in complex injectables and hospital products

BRIDGEWATER, N.J., July 17, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), today announced that it has received U.S. Food and Drug Administration (FDA) approval for additional strengths and vial presentations of iohexol injection, 350 mg iodine/mL

Amneal Expands Iohexol Injection Portfolio with U.S. FDA Approval of Additional Strengths and Presentations

Fri, 17 Jul 2026 08:00:00 -0400

Approval of iohexol injection 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials, and 300 mg iodine/mL in 50 mL vial, significantly expands Amneal’s injectable contrast portfolio
Portfolio now positioned to address the majority of U.S. iohexol injection market demand across key presentations
Demonstrates Amneal’s continued leadership in complex injectables and hospital products

Amneal Expands Iohexol Injection Portfolio with U.S. FDA Approval of Additional Strengths and Presentations

Fri, 17 Jul 2026 08:00:00 -0400

Approval of iohexol injection 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials, and 300 mg iodine/mL in 50 mL vial, significantly expands Amneal’s injectable contrast portfolio
Portfolio now positioned to address the majority of U.S. iohexol injection market demand across key presentations
Demonstrates Amneal’s continued leadership in complex injectables and hospital products

Amneal Expands Iohexol Injection Portfolio with U.S. FDA Approval of Additional Strengths and Presentations

Fri, 17 Jul 2026 08:00:00 -0400

Approval of iohexol injection 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials, and 300 mg iodine/mL in 50 mL vial, significantly expands Amneal’s injectable contrast portfolio
Portfolio now positioned to address the majority of U.S. iohexol injection market demand across key presentations
Demonstrates Amneal’s continued leadership in complex injectables and hospital products

Amneal Pharmaceuticals (AMRX) PT Raised to $23 at UBS

Wed, 15 Jul 2026 08:53:53 -0400

UBS analyst Ashwani Verma raised the price target on Amneal Pharmaceuticals (NASDAQ: AMRX) to $23.00 (from $19.00) while maintaining a Buy rating.

Amneal to Report Second Quarter 2026 Results on July 30, 2026

Thu, 09 Jul 2026 16:05:00 -0400

BRIDGEWATER, N.J., July 09, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”), today announced it will report second quarter 2026 financial results on Thursday, July 30, 2026, before market open. The Company will host an audio webcast at 8:30 a.m. ET.

The financial results and live webcast will be available through the Investor Relations section of the Company's website at investors.amneal.com. Individuals may register for the webcast by clicking here. To access the call by phone, dial 1 (833) 461-5787 (U.S.) or view a list of

Amneal to Report Second Quarter 2026 Results on July 30, 2026

Thu, 09 Jul 2026 16:05:00 -0400

Amneal to Report Second Quarter 2026 Results on July 30, 2026

Thu, 09 Jul 2026 16:05:00 -0400

Amneal to Report Second Quarter 2026 Results on July 30, 2026

Thu, 09 Jul 2026 16:05:00 -0400

Alkermes terminates authorized generic supply deal with Amneal

Wed, 08 Jul 2026 08:10:43 -0400

Alkermes plc (NASDAQ: ALKS) and Amneal Pharmaceuticals LLC have terminated an authorized generic product supply agreement, according to an 8-K filing dated July 6, 2026.

The agreement, originally entered into on September 9, 2025, had granted Amneal rights to distribute and sell a limited quantity of an authorized generic version of Vivitrol (naltrexone for extended-release injectable suspension) in the United States for a one-year term.

Alkermes notified Amneal that it had not met certain terms of the agreement. Before the remediation period expired, Amneal informed Alkermes that it did not wish to order any batches under the agreement.

Alkermes stated that no penalties

Alkermes terminates authorized generic supply deal with Amneal

Wed, 08 Jul 2026 08:10:43 -0400

Alkermes plc (NASDAQ: ALKS) and Amneal Pharmaceuticals LLC have terminated an authorized generic product supply agreement, according to an 8-K filing dated July 6, 2026.

Alkermes stated that no penalties

FDA selects seven participants for precheck pilot program to advance U.S. drug manufacturing

Mon, 29 Jun 2026 16:29:25 -0400

(Updated - June 29, 2026 4:29 PM EDT)

FDA selects seven participants for precheck pilot program to advance U.S. drug manufacturing

US FDA: Amneal, Cellares, Eli Lilly, Fujifilm, Kriya, Kyowa Kirin, and Regeneron join FDA Precheck pilot.
US FDA to provide early technical guidance in Precheck pilot Phase 1.
US FDA: Selected participants will engage with FDA under a two-phase Precheck model.

FDA selects seven participants for precheck pilot program to advance U.S. drug manufacturing

Mon, 29 Jun 2026 16:29:25 -0400

(Updated - June 29, 2026 4:29 PM EDT)

FDA selects seven participants for precheck pilot program to advance U.S. drug manufacturing

US FDA: Amneal, Cellares, Eli Lilly, Fujifilm, Kriya, Kyowa Kirin, and Regeneron join FDA Precheck pilot.
US FDA to provide early technical guidance in Precheck pilot Phase 1.
US FDA: Selected participants will engage with FDA under a two-phase Precheck model.

FDA selects seven participants for precheck pilot program to advance U.S. drug manufacturing

Mon, 29 Jun 2026 16:29:25 -0400

(Updated - June 29, 2026 4:29 PM EDT)

FDA selects seven participants for precheck pilot program to advance U.S. drug manufacturing

US FDA: Amneal, Cellares, Eli Lilly, Fujifilm, Kriya, Kyowa Kirin, and Regeneron join FDA Precheck pilot.
US FDA to provide early technical guidance in Precheck pilot Phase 1.
US FDA: Selected participants will engage with FDA under a two-phase Precheck model.

FDA selects seven participants for precheck pilot program to advance U.S. drug manufacturing

Mon, 29 Jun 2026 16:29:25 -0400

(Updated - June 29, 2026 4:29 PM EDT)

FDA selects seven participants for precheck pilot program to advance U.S. drug manufacturing

US FDA: Amneal, Cellares, Eli Lilly, Fujifilm, Kriya, Kyowa Kirin, and Regeneron join FDA Precheck pilot.
US FDA to provide early technical guidance in Precheck pilot Phase 1.
US FDA: Selected participants will engage with FDA under a two-phase Precheck model.

FDA selects 7 companies for domestic drug manufacturing pilot

Mon, 29 Jun 2026 16:20:42 -0400

The U.S. Food and Drug Administration has selected seven companies to participate in its PreCheck Pilot Program, an initiative aimed at supporting the development of new domestic pharmaceutical manufacturing facilities.

The FDA launched the program on February 1, 2026, following Executive Order 14293 signed by President Trump in May 2025. Between February 1 and March 1, 2026, the agency received more than 80 requests to participate. FDA drug and biologic experts evaluated all requests using a scoring framework that considered products to be manufactured, stage of facility development, anticipated timelines, and manufacturing innovation.