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Halia Therapeutics Receives FDA Fast Track Designation for Ofirnoflast (HT-6184) in Lower-Risk Myelodysplastic Syndromes

Halia Therapeutics Inc a clinicalstage biopharmaceutical company developing firstinclass therapies targeting inflammasomedriven disease biology today announced that the US Food and Drug Administration FDA

SK Life Science, Inc. Announces FDA Acceptance for Review of New Drug Application for Cenobamate Oral Suspension

SK Life Science Inc a subsidiary of SK Biopharmaceuticals Co Ltd today announced that the US Food and Drug Administration FDA has accepted for review the New Drug Application NDA for an investigational

Takeda’s Zasocitinib Significantly Outperforms Deucravacitinib in Head-to-Head Phase 3 Psoriasis Study, Promising to Redefine Oral Treatment Expectations

Takeda TSENYSETAK announced positive topline results for the Phase randomized multicenter doubleblind study comparing zasocitinib TAK an investigational nextgeneration

U.S. FDA Accepts Takeda's Application for Intravenous ENTYVIO® (vedolizumab) in Pediatric Ulcerative Colitis and Crohn's Disease

Takeda today announced the US Food and Drug Administration FDA has accepted for review its supplemental Biologics License Application sBLA for intravenous IV ENTYVIO vedolizumab for the treatment

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Jun 2026

MedTech Summit 2026

JW Marriott Hotel Berlin, Berl...

16 - 17

Jun 2026

LogiPharma Asia 2026

Equarius Hotel, Singapore

16 - 18

Jun 2026

CPHI & PMEC China 2026

Shanghai New International Exp...

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Jun 2026

PDA Sterile Manufacturing & Regulatory Excellence

Novotel Bangkok on Siam Square...

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Jun 2026

CCT 2026

Barcelona, Spain

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Jun 2026

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Jun 2026

6th Edition Drug Safety Symposium 2026

Courtyard by Marriott, Mumbai,...

25 - 26

Jun 2026

LATEST NEWSRead more...

Inhibrx Receives FDA Filing Acceptance for Ozekibart in Conventional Chondrosarcoma

Inhibrx Biosciences has announced that the US Food and Drug Administration FDA has accepted its Biologics License Application BLA for ozekibart INBRX for the treatment of patients with unresectable or metastatic conventional chondrosarcoma

Harbour BioMed’s IND Application for HBM7004 Accepted in China for Advanced Solid Tumours

Harbour BioMed has announced that Chinas National Medical Products Administration NMPA has accepted the Investigational New Drug IND application for HBM for the treatment of advanced solid tumours

Orionis Biosciences Expands Partnership with Novartis to Develop Molecular Glue Therapies

Orionis Biosciences has entered into a multiyear collaboration with Novartis to discover and develop molecular glue medicines targeting difficulttoaddress diseases across multiple therapeutic areas

Zai Lab Secures China Approval for TIVDAK in Recurrent or Metastatic Cervical Cancer

Zai Lab has received approval from Chinas National Medical Products Administration NMPA for TIVDAK tisotumab vedotin for injection to treat adult patients with recurrent or metastatic cervical cancer whose disease has progressed during or after chemotherapy

Johnson & Johnson to Acquire Firefly Bio to Strengthen Oncology Pipeline

Johnson Johnson has signed a definitive agreement to acquire biotechnology company Firefly Bio Inc for billion in cash

Alvotech Announces FDA Acceptance of BLA for Proposed Entyvio Biosimilar AVT16

Alvotech has announced that the US Food and Drug Administration FDA has accepted for review a Biologics License Application BLA for AVT a proposed interchangeable biosimilar to Entyvio vedolizumab for intravenous administration