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BioPharma Drug Approval

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

Lecanemab Receives Priority Review Status in Japan

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Chri...

January 30, 2023 | News

Alpha Biopharma Submits New Drug Application for Zorifertinib

Alpha Biopharma, a developer of innovative drugs, announces that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA...

January 30, 2023 | News

Dr. Reddy’s successfully completes full set of clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr. Reddy’s”), a g...

January 23, 2023 | News

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