AstraZeneca’s new lupus drug receives FDA approval
[ad_1] The US Food and Drug Administration on Monday approved a new drug for the treatment of adults with the most common type of lupus, moderate to severe. AstraZeneca’s Saphnelo has fewer side effects than standard treatments and is effective for serious diseases. The approval of the drug has caused excitement in the lupus community. […]
MDMA and FDA approval process
[ad_1] People are excited about the state of MDMA (also called ecstasy). And there are good reasons.As last month in New York Times: …People who receive MDMA during treatment [in clinical trials] Compared with patients receiving treatment and ineffective placebo, the severity of their symptoms was significantly reduced. After two months of treatment, 67% of […]
How is a full FDA approval different from an emergency use authorization?
[ad_1] Moderna announced on Tuesday that it has begun a rolling submission process to fully approve the U.S. Food and Drug Administration’s adult COVID-19 vaccine. Moderna CEO Stéphane Bancel will continue to submit data from its phase 3 clinical trial to US regulators to support its request for full approval Say. The company will roll […]
Were Some Vaginal Mesh Devices Marketed Without FDA Approval?
The Life Solutions Group discusses a recent report regarding claims that a transvaginal mesh manufacturer marketed the device without FDA approval.
Glaucoma Pipeline Assessment – ??FDA, EMA and PMDA Approvals,
DelveInsight’s Glaucoma Pipeline Insight, 2022 report provides deep insights into 70+ companies and 70+ pipeline drugs in the glaucoma pipeline landscape.” It includes the glaucoma pipeline Drug profiles, including clinical and non-clinical stage products. It also includes the evaluation of glaucoma therapeutics by product type, stage, route of administration and molecule type. It also highlights […]
HeartFlow Receives FDA 510(k) Clearance for its Plaque Analysis and
MOUNTAIN VIEW, Calif., Oct. 18, 2022 (GLOBE NEWSWIRE) — HeartFlow, Inc., the leader in revolutionary precision heart care, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two new AI-enabled products: plaque analysis and timetable Analysis. With its expanded product portfolio, HeartFlow is the first and only company to offer non-invasive […]
Todos Medical receives two letters of approval from the USPTO for
New York, NY and Tel Aviv, ISRAEL, September 30, 2022 (GLOBE NEWSWIRE) – via NewMediaWire — All Medical, Ltd. TOMDF, a comprehensive medical diagnostics and related solutions company, announced today that it has received two letters of acceptance from the United States Patent & Trademark Office (USPTO) for patent applications covering the company’s Fourier Transformed […]
Bladder Cancer Pipeline Review – FDA, EMA and PMDA
DelveInsight’s Bladder Cancer Pipeline Insight, 2022 report provides comprehensive insights into 100+ companies and 100+ pipeline drugs in the bladder cancer pipeline landscape. It covers the pipeline drug profiles, including both clinical and non-clinical stage products. It also includes therapeutic evaluation by product type, stage, route of administration and molecule type. It also highlights the […]
Major Depressive Disorder Pipeline Assessment – ??FDA, EMA and
“The DelveInsight Major Depressive Disorder Pipeline Insight 2022 report provides comprehensive insights into 75+ companies and 75+ pipeline drugs in the Major Depressive Disorder pipeline landscape” It covers the pipeline drug profiles for Major Depressive Disorder, including clinical and non-clinical stage products. It also covers the evaluation of major depressive disorder therapeutics by product type, […]
(ENLV) – Enlivex receives notice of approval for US patent
Nes-Ziona, Israel, Sept. 6, 2022 (GLOBE NEWSWIRE) — Enlivex Therapeutics Ltd. ENLV the “Company”))), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis and solid tumors, announced today that the U.S. Patent and Trademark Office has received a statement of approval for the Patent Application No. 15/551,284. Once granted, the resulting […]
FDA reviews ALS drug after lobbying by patients, politicians
[ad_1] When a patient is battling a terminal illness and wants an experimental drug, how much evidence does a regulator need to show it works before approving it? This is the question behind many of the FDA’s toughest decisions, including last year’s Controversial approval Aduheim. Many experts — including the agency’s own outside advisers — […]
Moderna seeks FDA authorization for 4th dose of COVID shot
[ad_1] Drugmaker Moderna asked the Food and Drug Administration on Thursday to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults. The request is broader than rival pharmaceutical company Pfizer’s request earlier this week for the regulator to approve a booster shot for all seniors. In a press release, […]