Nasdaq12d
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 ...
Nasdaq13d
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 ...
Nasdaq5d
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 ...
Nasdaq6d
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 ...
Nasdaq11d
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 ...
Nasdaq12d
FDA Approves Lilly's Omvoh For Crohn's Disease Treatment
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 ...
Nasdaq10d
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 ...
Novo Nordisk announces FDA approval of Ozempic for kidney disease risk
Novo Nordisk (NVO) announced that the Food and Drug Administration has approved Ozempic to reduce the risk of kidney disease worsening, kidney ...
Nasdaq27d
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 ...
D.C.'s Vanda Pharmaceuticals battling FDA on multiple fronts
A D.C. drugmaker is fighting the FDA on multiple fronts, from trying protect its intellectual property from generic ...
Strong Outlook for Cartesian Therapeutics: FDA SPA Agreement and Positive Phase 2b Results Boost Confidence in Descartes-08
Mitchell Kapoor, an analyst from H.C. Wainwright, reiterated the Buy rating on Cartesian Therapeutics (RNAC – Research Report). The associated ...
Nasdaq26d
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 ...