Nasdaq3d
Alvotech: FDA To Review BLA For AVT05 - Quick Facts
The FDA review process is anticipated to be completed ... and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New ...
Nasdaq3d
Invivyd Submits Updated Immunobridging Data To FDA For PEMGARDA EUA Amendment
Invivyd has continued to provide timely updates to the FDA since its initial submission ... author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew ...
Nasdaq3d
Cartesian Therapeutics Secures FDA SPA Agreement For Phase 3 AURORA Trial
Descartes-08 has received Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation from the FDA for MG and other ... reflect those of Nasdaq, Inc. Founded in the late 1990s ...
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 ...
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 ...
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 ...
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 ...
Vertex gets FDA approval for non-opioid pain reliever
Shares of Vertex Pharmaceuticals (NASDAQ:VRTX) rose 3% in post-market trading Thursday on news the company had received FDA ...
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 ...