Policy
Leerink analysts hailed the deals as a sign that President Trump “is unlikely to attack the industry in 2026.”
FEATURED STORIES
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
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The FDA has lifted the clinical hold it had placed on the Phase Ib study following the occurrence of hematological malignancies.
Acadia Pharmaceuticals announced the approval of Daybue (trofinetide) as the first and only drug to treat Rett Syndrome, a rare, neurodegenerative disorder affecting primarily girls.
An independent panel of advisers voted to approve Genentech’s Polivy after internal FDA staff raised concerns regarding the efficacy and risk-benefit profile as a first-line treatment for large B-cell lymphoma.
The FDA set a decision date of July 6, 2023 for Eisai and Biogen’s recently approved Alzheimer’s drug, Leqembi, Eisai announced Monday.
With the results from the CLEAR outcomes study, Esperion is poised for a major inflection in sales and is targeting blockbuster status, said CEO Sheldon Koenig on an investor call Monday.
The FDA’s Oncologic Drugs Advisory Committee will meet March 9 to discuss Roche’s sBLA for Polivy in first-line DLBCL, while Acadia awaits potential approval of the first therapy for Rett Syndrome.
Sen. Bernie Sanders (I-VT), chairman of the Senate’s Health, Education, Labor and Pensions Committee, sent a letter to Sanofi and Novo Nordisk urging them to lower insulin prices.
In 2022, Elon Musk’s Neuralink tried – and failed – to secure permission from the FDA to run a human trial of its implantable brain-computer interface, according to a report published Thursday.
Citing lack of efficacy evidence, the FDA rejected Cytokinetics’ heart failure hopeful omecamtiv mecarbil in a decision announced Tuesday evening.
Billy Dunn, director of the FDA’s Office of Neuroscience, is stepping down from his post to “explore other opportunities,” according to an internal FDA e-mail.