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BioPharma Drug Approval

Sarepta Therapeutics Secures FDA Approval for Expanded Use of ELEVIDYS in Duchenne Muscular Dystrophy Patients

Sarepta Therapeutics, the leader in precision genetic medicine for rare diseases, today announced U.S. Food and Drug Administration (FDA) approv...

June 21, 2024 | News

Dizal's Golidocitinib Approved in China as First JAK1-Only Inhibitor for Relapsed or Refractory Peripheral T-Cell Lymphoma

Golidocitinib is a first-in-class Janus kinase 1 (JAK1) only inhibitor approved for the treatment of r/r PTCL based on results from the multinational piv...

June 20, 2024 | News

Menarini Expands Partnership with Pharmacosmos to Bring Innovative Iron Deficiency Treatment to Singapore and Malaysia

Menarini Asia-Pacific (Menarini) announced that it has expanded its partnership with Pharmacosmos A/S (Pharmacosmos), to include exclusive rights to ...

June 19, 2024 | News

FDA Clears Zymeworks' ZW171 for Mesothelin-Expressing Cancers

“We are excited to reach this R&D milestone with ZW171, reflecting our commitment to advancing innovative therapies for cancer treatment,...

June 18, 2024 | News

SciRhom GmbH Secures Approval for Clinical Trial Application of SR-878 in Austria

SciRhom GmbH, a biopharmaceutical company pioneering the development of first-in-class therapeutic antibodies, announced the approval of a clinical trial a...

June 14, 2024 | News

Gilead and Kite Oncology Announce Approval of Yescarta® for Early Treatment of DLBCL in Singapore

**-- In ZUMA-7, Yescarta Patients with DLBCL were 2.5 Times More Likely than SOC to be Alive at Two Years Without Cancer Progression or Nee...

June 10, 2024 | News

Genetic Signatures Receives FDA Clearance for EasyScreen™ Gastrointestinal Parasite Detection Kit

Genetic Signatures Limited a global molecular diagnostics company announces that the US Food & Drug Administration ("FDA") has cleared the Compan...

June 05, 2024 | News

Telix Pharmaceuticals Completes BLA Submission to FDA for Breakthrough Kidney Cancer Imaging Agent TLX250-CDx

Telix Pharmaceuticals announces that it has completed the submission of a Biologics License Application (BLA) to the United States (U.S.) Food an...

June 03, 2024 | News

Kexing Biopharm’s Subsidiary Receives Approval for Clinical Trials of Innovative GB08 Growth Hormone

Kexing Biopharm announced that Shenzhen Kexing Pharmaceutical Co., Ltd., its wholly-owned subsidiary, recently received a Notice of Approval for Drug Clini...

May 31, 2024 | News

FDA Approves Bkemv as First Interchangeable Biosimilar to Soliris

U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare di...

May 29, 2024 | News

Ractigen Therapeutics' saRNA Drug RAG-01 Receives Fast Track Designation from FDA

Ractigen Therapeutics, a pioneering developer of small activating RNA (saRNA) therapeutics, proudly announces that its flagship program, RAG-01, has been g...

May 22, 2024 | News

Ractigen Therapeutics Receives IND Approval for Phase 1 ALS Clinical Trials in China

Ractigen Therapeutics, a clinical-stage pharmaceutical company committed to developing pioneering therapies, announces that the Center for Drug ...

May 16, 2024 | News

EFECON® Becomes First Approved Therapy for IgAN in China, Offering Hope to Millions with Improved Patient Care and Disease Management

Everest Medicines, a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative medicines ...

May 15, 2024 | News

Eisai's Antiepileptic Drug Fycompa® Gains Approval in China for Additional Indication

Eisai Co., Ltd. announced that it has received approval in China for the additional indication of its in-house discovered antiepileptic drug (AED) Fycompa&...

May 14, 2024 | News

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