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BioPharma Drug Approval

Vertex Pharmaceuticals Receives FDA Clearance for Innovative ADPKD Drug Trial

Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) f...

March 22, 2024 | News

Oscotec Inc. Gains FDA Orphan Drug Designation for Promising ITP Treatment Cevidoplenib

Oscotec Inc. has secured orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its SYK inhibitor, Cevidoplenib, to treat immun...

March 22, 2024 | News

Singapore Approves Everest Medicines' NEFEGAN® for Adult Primary IgA Nephropathy

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, development, manufacturing and commerc...

March 20, 2024 | News

KeChow Pharma's Tunlametinib Receives Historic Approval in China for Advanced Melanoma Treatment

KeChow Pharma, a commercial-stage pharmaceutical company focused on developing and commercializing differentiated small molecule therapeutics for cancer, t...

March 19, 2024 | News

FDA Grants Fast Track Designation to ImmVira's MVR-T3011 IT for Advanced Head and Neck Cancer

ImmVira's groundbreaking oncolytic virus therapy, MVR-T3011 IT intratumoral injection, has been awarded Fast Track designation by the U.S. Food and Drug Ad...

March 18, 2024 | News

CStone's Sugemalimab Granted Historic Approval in China for Gastric Cancer Treatment

CStone Pharmaceuticals has achieved a significant milestone with the approval of sugemalimab (Cejemly®) by the National Medical Products Administration...

March 18, 2024 | News

BeiGene's TEVIMBRA Wins FDA Nod for Advanced Esophageal Cancer Post-Chemotherapy

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has app...

March 15, 2024 | News

FDA Approves Rezdiffra for Noncirrhotic NASH with Liver Fibrosis

U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with m...

March 15, 2024 | News

Mirum Pharmaceuticals Announces FDA Approval of LIVMARLI for Cholestatic Pruritus in PFIC Patients

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM), a leader in developing innovative treatments for rare liver diseases, has proudly announced the...

March 14, 2024 | News

FDA Grants Nefecon® Orphan Drug Exclusivity for Seven Years

Everest Medicines licensing partner Calliditas Therapeutics AB announced that the U.S. FDA has granted an orphan drug exclusivity period of seven yea...

March 12, 2024 | News

Macau Poised to Be First in Asia to Approve Everest's Etrasimod for Ulcerative Colitis

Macau is on course to become the first of Everest's Asian territories to get etrasimod approval -- Can provide access to patients in China's&nbs...

March 11, 2024 | News

TransThera Launches Global Phase 3 Trial for Cholangiocarcinoma in EU, Receives Orphan Drug Status for Tinengotinib from EMA

TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced that the randomized, controll...

March 11, 2024 | News

VISEN Pharmaceuticals' Groundbreaking Growth Hormone Therapy BLA Accepted by China NMPA

VISEN Pharmaceuticals (VISEN), an innovative biopharmaceutical company focused on endocrine diseases, announced that the Biologics License Application (BLA...

March 08, 2024 | News

Epitomee® Submits Innovative Weight Loss Capsule for FDA Clearance

The Epitomee® capsule is designed for oral use and stands out as a drug-free option, clinically validated to be both effective and safe for adu...

March 07, 2024 | News

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