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AstraZeneca’s Tropion-Lung01 Phase III Trial Positive Outcomes; Biogen’s LEQEMBI South Korea Approval; AltruBio’s $225M Series B Funding; GSK’s Depemokimab Positive Phase III Severe Asthma Results; Roche’s Inavolisib FDA Breakthrough Therapy Designation

The Tropion-Lung01 Phase III Trial Reveals that Datopotamab Deruxtecan Significantly Enhanced Overall Survival in Advanced Nonsquamous NSCLC Patients Compared to Chemotherapy The high-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which had previously met the dual primary endpoint o...

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Amgen’s IMDELLTRA FDA Approval; J&J’s Proteologix Acquisition; Bristol Myers Squibb’s BREYANZI FDA Approval; AbbVie and Gilgamesh Pharmaceuticals’ Agreement; Eisai’s LEQEMBI FDA Fast Track Status

IMDELLTRA Receives FDA Approval as the First T-Cell Engager Therapy for Advanced Small Cell Lung Cancer Amgen has reported that the FDA has approved IMDELLTRA™ (tarlatamab-dlle) for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following pl...

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Takeda and AC Immune’s Alzheimer’s Deal; Eli Lilly’s Donanemab FDA Review; Bristol Myers Squibb’s Phase III CheckMate -73L Trial Result; Regeneron Pharmaceuticals’ Dupixent sBLA; Excision BioTherapeutics’ EBT-101 Phase I/II Trial Results

Takeda and AC Immune Ink Exclusive Deal for Active Immunotherapy in Alzheimer’s, Focusing on Amyloid Beta Takeda and AC Immune SA have unveiled an exclusive global option and licensing pact concerning AC Immune’s active immunotherapies directed at harmful variants of amyloid beta (Abeta), notably ACI-24.060, int...

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Boehringer Ingelheim’s Diabetic Macular Ischemia Study; Novartis’ Mariana Oncology Acquisition; Astellas and Poseida Therapeutics Partnership; Prime Medicine’s PM359 IND; Pfizer’s TIVDAK FDA Approval

Boehringer Ingelheim Announces Promising Findings From Groundbreaking Study on Diabetic Macular Ischemia  Boehringer Ingelheim released encouraging results from the HORNBILL Phase I/IIa trial of BI 764524, marking the pioneering investigation into a potential therapy for individuals with diabetic macular is...

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X4 Pharmaceuticals’ XOLREMDI FDA Approval; ONO to Acquire Deciphera Pharmaceuticals; Johnson & Johnson’s SIRTURO CHMP Approval; BeiGene’s Tislelizumab EC Approval; Sanofi’s Rilzabrutinib LUNA 3 Phase III Trial

FDA Greenlights XOLREMDI Capsules from X4 Pharmaceuticals for WHIM Syndrome Treatment X4 Pharmaceuticals has declared that the FDA has granted approval for XOLREMDI™ (mavorixafor) capsules to be utilized in individuals aged 12 and above who have WHIM syndrome (characterized by warts, hypogammaglobulinemia, infec...

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Ipsen and Skyhawk Therapeutics Partnership; SynOx Therapeutics’ Phase III Trial; Roche’s Alecensa FDA Approval; AbbVie’s RINVOQ Phase III SELECT-GCA Trial; AskBio’s AB-1002 FDA Fast Track Designation

Ipsen Partners with Skyhawk Therapeutics for RNA-Focused Research in Rare Neurological Disorders Ipsen and Skyhawk Therapeutics have entered into an exclusive global partnership to explore and create new small molecules that can influence RNA for rare neurological conditions. Under this agreement, Ipsen has the ...

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Roche’s Columvi Phase III STARGLO Trial; Novartis’ Fabhalta Latest Data; Vertex’s Alpine Immune Sciences Acquisition; Telix Pharmaceuticals’ TLX101-CDx Fast Track Designation; NovelMed’s NM5072 Orphan Drug Designation

Roche's Columvi Achieves Primary Endpoint of Prolonged Overall Survival in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Phase III STARGLO Trial Roche reported that the Phase III STARGLO trial successfully achieved its main goal of improving overall survival. The research revealed that in...

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AstraZeneca and Daiichi Sankyo’s Enhertu US Approval; Basilea’s ZEVTERA FDA Approval; Genmab’s ProfoundBio Acquisition; Rocket Pharmaceuticals’ RP-L102 EMA Approval; Alexion’s Ultomiris and Soliris AAN 2024 Data

Enhertu Receives US Approval as First HER2-focused Treatment for Metastatic Solid Tumors, Independent of Tumor Origin AstraZeneca and Daiichi Sankyo's drug Enhertu (trastuzumab deruxtecan) has gained approval in the United States for treating adult patients with inoperable or metastatic HER2-positive (IHC 3+) so...

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AstraZeneca’s Voydeya FDA Approval; Akebia’s Vafseo FDA Approval; Bristol Myers Squibb’s Phase III YELLOWSTONE Trial Update; Astellas’ IZERVAY FDA Approval; AstraZeneca’s Truqap and Faslodex MHLW Approval

Voydeya Receives FDA Approval as Supplemental Treatment with Ravulizumab or Eculizumab for Managing Extravascular Hemolysis in Adult Patients with PNH Voydeya (danicopan) has received approval in the United States for use alongside ravulizumab or eculizumab in treating extravascular hemolysis (EVH) in adults dia...

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Regeneron’s Odronextamab BLA; Novo Nordisk’s Cardior Pharmaceuticals Acquisition; Novartis’ Fabhalta CHMP Approval; Idorsia’s TRYVIO FDA Approval; AbbVie’s Landos Biopharma Acquisition

Regeneron Updates Progress on Biologics License Application for Odronextamab Regeneron Pharmaceuticals, Inc. has announced that the FDA has issued Complete Response Letters (CRLs) regarding the Biologics License Application (BLA) for odronextamab in cases of relapsed/refractory (R/R) follicular lymphoma (FL) and...

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