BioPharma Drug Approval
Revolutionizing Drug Development: How AI is Reducing Time and Costs of Bringing New Treatments to Market
The development of new drugs is a lengthy and costly process that can take several years and cost billions of dollars. However, the emergence of artificial...
March 10, 2023 | Opinion
Estrella Biopharma's ARTEMIS® T Cell Therapy EB103 IND Cleared by FDA for B-Cell Lymphomas Clinical Trial
Estrella Biopharma, Inc. ("Estrella"), a biopharmaceutical company whose mission is to harness the evolutionary power of the human immune system to transfo...
March 09, 2023 | News
Mallinckrodt's CELLEX® ECP System Reimbursed in Japan for cGvHD Treatment
– CELLEX ECP is now available for reimbursement in Japan for patients who are steroid-resistant or -intolerant and suffering from cGvHD &nd...
March 09, 2023 | News
Kevzara® (sarilumab) Approved by FDA as First and Only Biologic Indicated for Patients with Polymyalgia Rheumatica
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Kevzara® (...
March 01, 2023 | News
Teva Announces FDA Approval of AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets
New once-daily AUSTEDO XR regimen now approved in 6, 12, and 24 mg tablet strengths AUSTEDO is the only vesicular monoamine transporter 2 (VMAT2) inhibi...
February 20, 2023 | News
Johnson // Becker, PLLC Files Second Tepezza Hearing Loss Lawsuit
Tepezza, a drug prescribed for the treatment of thyroid eye disease, is allegedly responsible for long-term hearing issues in multiple instances. In a law...
February 20, 2023 | News
Biosyngen has obtained FDA IND clearance of BRG01 for Phase I/II clinical trials against Nasopharyngeal Cancer
Prior to this approval from the US FDA, Biosyngen's BRG01 was granted IND by China CDE on December 14th, 2022. In addition, China CDE has acknowledged...
February 18, 2023 | News
Everest Medicines Announces South Korea Grants Fast Track Review Designation to Nefecon for the Treatment of Primary IgA Nephropathy
This demonstrates the urgent unmet medical needs for Nefecon, as Everest also received Priority Review status for the New Drug Application (NDA) of Nefecon...
February 10, 2023 | News
EYLEA now approved to treat five retinal conditions caused by ocular angiogenesis
ROP is a leading cause of childhood blindness worldwide Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug...
February 09, 2023 | News
Tavneos® (avacopan) approved in Australia for the treatment of ANCA-associated vasculitis
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced the Therapeutic Goods Administration (TGA) in Australia has approved Tavneos&r...
February 07, 2023 | News
New technology designed to help inform real-time clinical decisions during kidney stone procedures
Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LithoVue™ Elite Single...
February 06, 2023 | News
Regulatory filing for house dust mite allergy tablet accepted for review in China
The BLA, for treatment of persistent moderate-to-severe HDM allergic rhinitis in patients aged 12–65 was submitted in late December 2022. S&...
February 03, 2023 | News
FDA 21 CFR Part 11: 7 Ways to Avoid Noncompliance
The FDA’s guidance for the creation and storage of electronic signatures and records as official documentation has held fast for 30 years. However,...
February 03, 2023 | News
FDA Approves First Oral Treatment for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis
"With an oral drug option in addition to the FDA-approved injection options, adults with chronic kidney disease on dialysis now have multiple ways to treat...
February 02, 2023 | News
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