Nasdaq7d
Biogen Says FDA And EMA Accept Applications For Higher Dose Regimen Of Nusinersen In SMA
(RTTNews) - Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the ... do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s ...
Nasdaq8d
Elicio Therapeutics Receives Supportive FDA Feedback for ELI-002 Phase 3 Study Design, Gains Momentum for Cancer Immunotherapy Development
Received supportive FDA feedback on key elements of the potential ... Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company ...
Nasdaq13d
FDA Approves AstraZeneca's Calquence For Patients With Untreated Mantle Cell Lymphoma
(RTTNews) - AstraZeneca (AZN), on Friday, announced that the FDA has approved CALQUENCE in ... author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew ...
FDA approves Vertex's first-in-class non-opioid analgesic for acute pain
Today, the U.S. Food and Drug Administration (FDA) gave its approval to Vertex Pharmaceuticals' (NASDAQ: NASDAQ:VRTX) Journavx (suzetrigine) 50 milligram oral tablets. This new drug is a non-opioid ...
Nasdaq12d
FDA Okays AstraZeneca And Daiichi's Datroway For Metastatic HR-Positive, HER2-Negative Breast Cancer
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
Vertex Pharmaceuticals’ non-opioid Journavx approved for pain by FDA
Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class ...
First New Non-Opioid Painkiller in Decades Gets FDA Approval
Vertex Pharmaceuticals won U.S. approval for the first new non-opioid painkiller in decades, which could be a blockbuster if the company can persuade insurers and doctors to embrace the non-addictive ...
Nasdaq29d
Biotech Stocks Facing FDA Decision In January 2025
In 2024, the FDA approved 50 novel drugs ... views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
Nasdaq20d
FDA Accepts J&J's Filing for Autoimmune Disease Drug Nipocalimab
The FDA filing is supported by data from the phase ... We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators,and more, that ...
Nasdaq28d
ANI Pharmaceuticals Launches Prucalopride Tablets Following FDA Approval
(Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company has launched Prucalopride ...
Nasdaq14d
J&J Seeks FDA Nod for Non-Muscle Invasive Bladder Cancer Drug
Johnson & Johnson JNJ has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational drug-device combination to treat certain patients with non-muscle invasive ...
Nasdaq15d
Tempus Announces the National Launch of FDA-Approved xT CDx Test
Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced the national launch of the company’s FDA-approved, NGS-based ...