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The report comes just two days after Novartis announced its own Parkinson’s drug failure.

Accord BioPharma , Inc. announced that the U.S. Food and Drug Administration (FDA) has approved HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.

Edesa Biotech, Inc. announced today that its first-in-class drug candidate has been selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for evaluation in a U.S. government-funded clinical study.

Axogen, Inc. is pleased to announce that it has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for licensure of Avance Nerve Graft ® on May 15, 2024.

The Association for Diagnostics & Laboratory Medicine released the results of a survey that ADLM conducted to determine how the Food and Drug Administration’s final laboratory developed tests rule will impact patient access to essential tests.

Cassava Sciences has revealed the late-stage clinical failure of controversial Alzheimer’s drug simulfilam. The company had pledged to share the results whether “good, bad or ambiguous.”

AbbVie’s blockbuster Humira held 105 patents, shielding the anti-inflammatory drug from biosimilar competition for more than 20 years. Proposed reforms could help prevent companies from extending exclusivity with such patent thickets.