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Earlier this year, Amgen refused the FDA’s request to withdraw Tavneos from the market. Now, two researchers who participated in the original study to support the drug’s approval claim they did not know the primary endpoint was readjudicated after the study was unblinded.

Retractable Technologies, Inc. reports the following information relating to the year ended December 31, 2023.

Retractable Technologies, Inc. reports that the FDA Safety Communication “Evaluating Plastic Syringes Made in China for Potential Device Failures” on November 30, 2023 does not refer to syringes from Retractable Technologies Inc.

Retractable Technologies, Inc. (NYSE American: RVP) reports total net sales of $7.6 million for the first three months of 2024 and an operating loss of nearly $3.0 million for the period, as compared to total net sales for the same period last year of $11.0 million and an operating loss of $2.7 million.

Weeks after Boehringer Ingelheim and Eli Lilly retracted billions of dollar in German commitments, the nation’s government is reportedly changing a contentious element of its planned healthcare reforms.

The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January.

Retractable Technologies, Inc. reports the following information relating to the year ended December 31, 2022.

Retractable Technologies, Inc. reports that its loss from operations was $8.7 million for the first nine months of 2023 and that it had an operating loss of $936 thousand for the third quarter of 2023, as compared to an operating income for the same periods last year of $7.0 million for the first nine months of 2022 and an operating loss of $691 thousand for the third quarter of 2022.