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) ...
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 ...
Eagle-Tribune5h
Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has ...
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 ...
Here’s Why Immunovant, Inc. (IMVT) Will Double in 2025
We recently compiled a list of the 12 Stocks That Will Double in 2025. In this article, we are going to take a look at where ...
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 ...
Nasdaq23d
Integra LifeSciences reports FDA warning letter related to quality system issues
In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...
Nasdaq20d
Pharma Stock Roundup: FDA Updates for JNJ, GSK, PFE, NVO's Expanded Deal
The FDA granted priority review designation to J&J’s biologics license application (BLA) seeking approval of nipocalimab for antibody-positive patients with gMG, a rare, autoantibody-driven disease.