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Astrazeneca & Daiichi Sankyo
NEWS

Daiichi Sankyo and AstraZeneca Report the EC Approval for Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: The EC has approved Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy; regulatory review is ongoing in China & Japan, as well as Australia, Canada, Singapore & Switzerland as part of Project Orbis Approval was backed by the global P-III (TROPION-Breast02)…
July 31, 2026

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NEWS

Kaigene Inks ~$378M Exclusive Licensing Agreement with Taisho Pharmaceutical for KG006 in Japan

Shots: Kaigene has entered into an exclusive licensing agreement with Taisho Pharmaceutical for the exclusive development & commercialization of KG006 in Japan As per the deal, Taisho will acquire exclusive rights to develop & commercialise KG006 in Japan, with Kaigene receiving $5M upfront, up to $22M & ¥57.5B (~$351M) in development, regulatory & sales milestones,…
July 31, 2026

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NEWS

Outlook Therapeutics Reports the US FDA Approval of Lytenava for Wet AMD 

Shots:  The US FDA has approved Outlook’s Lytenava (Bevacizumab-vikg) for wet AMD    Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized IgG1 MAb targeting VEGF  Additionally, the approval is expected to provide LYTENAVA with 12 years of Reference Product Exclusivity under the BPCIA  Ref:  Outlook Therapeutics |  Image: Outlook Therapeutics |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications.…
July 24, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in June 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon.  European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive…
July 21, 2026

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NEWS

Henlius Reports First Patient Dosing in P-I Trial of HLX18 (Biosimilar, Opdivo) in China 

Shots:  Henlius has dosed the first patient in China in the P-I (HLX18-MRST001) trial assessing its nivolumab biosimilar, HLX18, in patients with resected solid tumors  The study will compare HLX18 vs. Opdivo in patients with resected solid tumors, evaluating PK similarity, efficacy, safety, and immunogenicity following monotherapy  HLX18 is Henlius' nivolumab biosimilar candidate, developed under global biosimilar guidelines. Reference nivolumab is approved worldwide for multiple cancers, including melanoma, NSCLC, RCC, HCC, urothelial, gastric, esophageal, colorectal, and head & neck cancers  Ref: Henlius  |  Image: Henlius   | Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more…
July 16, 2026

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NEWS

Allergan Aesthetics (AbbVie)’s Boey to Temporarily Improve Glabellar Lines in Adults 

Shots:  The EC has approved Boey (trenibotulinumtoxinE) to improve the appearance of mod. to sev. glabellar lines in adults temporarily across all 30 EEA countries  Boey is Europe’s first and only rapid-onset, short-duration botulinum neurotoxin type E, with effects starting in as little as 8 hours and lasting 2–3 weeks.  Boey also received Health Canada approval…
July 16, 2026

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INSIGHTS+

The US FDA New Drug Approvals in June 2026 

Shots:  The US FDA approved three notable therapies in June 2026, spanning diagnostic imaging, infectious diseases, and ophthalmology, highlighting continued progress in precision diagnostics, antimicrobial innovation, and rare disease treatment.  Key approvals included Ambelvist (enhanced MRI detection of lesions), Utebzi (complicated urinary tract infections, including pyelonephritis), and Lumvoa (thyroid eye disease), expanding treatment and diagnostic options for patients with diverse clinical…
July 14, 2026

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NEWS

Formycon Partners with OneSource Specialty Pharma for Biosimilars 

Shots:  Formycon and OneSource Specialty Pharma have entered into a strategic manufacturing partnership for biosimilars  As per the deal, OneSource will act as Formycon’s strategic manufacturing partner, providing integrated Drug Substance (DS) and Drug Product (DP) manufacturing from its advanced biologics facility in Bangalore, India  The collaboration combines Formycon’s biosimilar development expertise with OneSource’s end-to-end biologics manufacturing capabilities to advance Formycon’s global biosimilar programs  Ref: Formycon |  Image:…
July 14, 2026

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NEWS

Henlius Reports First Patient Dosing in P-I Trial of HLX15-SC (Biosimilar, Darzalex Faspro) in the US 

    Shots:  Henlius has dosed the first U.S. patient in the global P-I HLX15-SC (HLX15-SC-NDMM-001) trial, a biosimilar version of Darzalex Faspro, as a 1L treatment for newly diagnosed multiple myeloma (NDMM)  The study will compare HLX15-SC vs. US-licensed Darzalex Faspro in transplant-ineligible NDMM patients, evaluating PK similarity, safety, tolerability, immunogenicity, and efficacy in combination with lenalidomide & dexamethasone (Rd)  HLX15 is an anti-CD38 daratumumab biosimilar candidate for…
July 13, 2026

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NEWS

Samsung Bioepis Partners with Teva  to Commercialize Opuviz  (Biosimilar, Eylea) in Canada 

 Shots:  Samsung Bioepis & Teva have entered into a license and commercialization agreement to commercialize Opuviz (Biosimilar, Eylea) in Canada  As per the deal, Samsung Bioepis will be responsible for the registration & manufacture of the products, while Teva Canada will hold commercialization rights  Opuviz was approved by Health Canada in October 2025 for wet AMD, CRVO/BRVO-related macular edema, DME, and mCNV. Samsung Bioepis' aflibercept biosimilar is also marketed in EU and South…
July 9, 2026

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