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BioPharma Drug Approval

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

Everest Medicines Announces South Korea Grants Fast Track Review Designation to Nefecon for the Treatment of Primary IgA Nephropathy

EYLEA now approved to treat five retinal conditions caused by ocular angiogenesis

Tavneos® (avacopan) approved in Australia for the treatment of ANCA-associated vasculitis

New technology designed to help inform real-time clinical decisions during kidney stone procedures

Regulatory filing for house dust mite allergy tablet accepted for review in China

FDA 21 CFR Part 11: 7 Ways to Avoid Noncompliance

FDA Approves First Oral Treatment for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis

Lecanemab Receives Priority Review Status in Japan

Alpha Biopharma Submits New Drug Application for Zorifertinib

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

Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ES-SCLC

Isohelix Files US FDA Pre-Submission for GeneFix Saliva DNA Collectors

FDA approves LEQEMBI™ (lecanemab-irmb) under the Accelerated Approval pathway for the treatment of Alzheimer's disease

Burning Rock Received FDA Breakthrough Device Designation for its OverC™ Multi-Cancer Detection Blood Test

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