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Samsung Biologics Expands U.S. Manufacturing Footprint with Acquisition of Human Genome Sciences from GSK

Shots: Samsung Biologics’ US subsidiary entered a definitive agreement to acquire 100% of Human Genome Sciences from GSK, securing its first US based manufacturing site in Rockville, Maryland As per the deal terms, Samsung Biologics will acquire the Rockville assets for $280M, with closing expected by end of Q1’26, while retaining 500+ employees to ensure…
5 days ago

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GSK Reports the FDA Approval of Exdensur (Depemokimab-ulaa) for Asthma with Eosinophilic Phenotype

Shots: FDA has approved GSK’s Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) with an eosinophilic phenotype following MHRA’s approval for both asthma & CRSwNP; regulatory review is ongoing in EU, Japan & China Approval was based on the P-III trials: SWIFT-1 (n=382) & SWIFT-2 (n=380) assessing Exdensur vs PBO, both in addition to SoC,…
December 17, 2025

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GSK Reports the CHMP Positive Opinion of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

Shots: CHMP recommended GSK's depemokimab as add-on maintenance therapy for asthma pts (≥12yrs.) with type 2 inflammation (eosinophilic) & as add-on therapy for inadequately controlled CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively; EC’s decision expected in Q1’26 SWIFT-1 (n=382) & SWIFT-2 (n=380) trials showed depemokimab reduced asthma exacerbations by 54% over 52wks. (1EP)…
December 15, 2025

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GSK Reports the US FDA Approval of Blujepa for Uncomplicated Urogenital Gonorrhoea (uGC)

Shots: The US FDA has approved GSK's Blujepa (gepotidacin) for the treatment of pts (≥12yrs.; ≥45kg) with uGC caused by Neisseria gonorrhoeae who have limited or no alternative options for treatment  Approval was backed by P-III (EAGLE-1) trial assessing Blujepa (2 doses × 3000mg; PO) vs ceftriaxone (500mg; IM) + azithromycin (1000mg; PO) in ~600 pts with…
December 12, 2025

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GSK’s Risvutatug Rezetecan Secures the US FDA’s Orphan Drug Designation for Treating SCLC

Shots: The US FDA has granted ODD to GSK’s risvutatug rezetecan (GSK5764227) for the treatment of small-cell lung cancer (SCLC) Designation was supported by preliminary P-I (ARTEMIS-001) trial data showing durable responses in pts with extensive-stage SCLC treated with risvutatug rezetecan GSK’227 is a B7-H3-targeted ADC developed by Hansoh Pharma for various solid tumors. GSK…
December 11, 2025

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GSK and LTZ Therapeutics
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GSK Collaborates with LTZ Therapeutics to Advance Myeloid Cell Engager Therapies in Oncology

Shots: GSK has entered into a strategic research collaboration with LTZ Therapeutics to advance the development of novel myeloid cell engagers (MCEs) in oncology, leveraging LTZ’s immune-engager platform Under the collaboration, GSK & LTZ aim to develop up to four MCE therapies for hematologic cancers & solid tumors, with GSK receiving an exclusive option to…
November 19, 2025

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GSK Collaborates with Empirico to Advance EMP-012 Across Inflammatory Respiratory Diseases

Shots: GSK has entered into a worldwide exclusive license agreement with Empirico to develop & commercialize EMP-012 As per the deal,Empirico will lead P-I development of EMP-012, following which GSK will take over global development, regulatory filings, & commercialization, with Empirico receiving $85M upfront, ~$660M in development, regulatory & commercial milestones, & tiered royalties on…
October 28, 2025

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GSK Secures Exclusive License to Syndivia’s ADC Candidate for Prostate Cancer

Shots: Syndivia has granted GSK exclusive global rights to develop and commercialize a preclinical ADC for the treatment of metastatic castration-resistant prostate cancer (mCRPC) As per the deal, GSK will handle global development, manufacturing, & commercialization of the ADC in exchange for an upfront payment, along with development & commercial milestone payments up to a total of…
October 27, 2025

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GSK’s Blenrep (Belantamab Mafodotin) Regimen Receives the US FDA’s Approval to Treat R/R Multiple Myeloma

Shots: The US FDA has approved Blenrep + BorDex for the treatment of r/r MM in adults who have received ≥1 prior therapy, incl. a proteasome inhibitor & an immunomodulatory agent. NDA under NMPA’s priority review Approval was based on P-III (DREAMM-7) trial assessing Blenrep (2.5mg/kg, IV, Q3W) in combination with BorDex for 8 cycles, then as a single…
October 24, 2025

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GSK’s Shingrix PFS Presentation Receives the CHMP’s Positive Opinion

Shots: The CHMP has recommended Shingrix in a PFS (Recombinant Zoster Vaccine or RZV), simplifying administration by eliminating vial reconstitution for the prevention of shingles (herpes zoster). EU marketing authorization is expected in December 2025 The opinion was based on data showing that the PFS matches the existing vaccine Shingrix combines glycoprotein E antigen with…
October 23, 2025

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