BioPharma Drug Approval

Aquavit Files Two IND's For Its Botulinum Toxin With FDA

Aquavit Holdings, the exclusive licensee of Huons Global's Botulinum Toxin in the USA and Canada, will officially unveil the Aquatox™ ...

 March 18, 2023 | Regulatory

Glenmark's GRC 54276 IND application accepted by US FDA for first-in-human study on advanced tumors

Glenmark Specialty SA, the subsidiary of Glenmark Pharmaceuticals Ltd., an innovation-driven, global pharmaceuticals company received acceptance from the U...

 March 17, 2023 | News

FDA approves expanded indication for Telix's Illuccix® for PSMA-directed therapy

The label expansion means Illuccix is now approved in the U.S. to identify and select patients who are candidates for the only FDA-approved prostate-specif...

 March 16, 2023 | News

FDA approves Abbisko Therapeutics' Pimicotinib for Phase III clinical trial

This is the first-ever global phase III trial for TGCT approved by NMPA and FDA. Pimicotinib (ABSK021)was granted BTD by FDA and CDE, discovered a...

 March 16, 2023 | News

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


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