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Fresenius Kabi
NEWS

Fresenius Kabi Reports FDA and EMA Acceptance of PB016 (Biosimilar, Entyvio) for Review

Shots: The US FDA and EMA have accepted the BLA & MAA, respectively, for PB016, a biosimilar version of Entyvio (vedolizumab) lyophilized vial for IV administration BLA was supported by an extensive development program assessing PB016 vs Entyvio, to evaluate its similarity to the reference product, consistent with regulatory requirements for biosimilar approval PB016 is…
August 3, 2026

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NEWS

Cytokinetics Reports MHRA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The MHRA has approved Cytokinetics’ Myqorzo (aficamten) for the treatment of adults with symptomatic (NYHA, class II-III) oHCM MHRA assessment was based on P-III (SEQUOIA-HCM) trial of Myqorzo (n=282), showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.8 vs 0 ml/kg/min Additionally, NICE has recommended aficamten for eligible…
July 30, 2026

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NEWS

Relation and GSK Partner to Advance Drug Discovery

Shots: Relation has entered a strategic research collaboration with GSK to generate large-scale human cellular perturbation datasets to understand disease biology & discover novel therapeutic targets Relation will generate large-scale perturbation datasets using advanced human cellular disease models & experimental systems to develop, validate, & train foundation models, incl. MORGAN, to investigate disease biology &…
July 30, 2026

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NEWS

Synlogic and Caldera Report Merger Agreement and Concurrent $278M Private Placement to Advance CLD-423

Shots: Synlogic & Caldera have agreed to merge in an all-stock transaction, forming a new holding company that will operate as Caldera Therapeutics & plans to list on Nasdaq under the ticker “CALD” Upon closing, Synlogic, Caldera, and private placement investors are expected to own ~2.3%, ~62.8%, and ~34.9% of the combined company, respectively, with…
July 30, 2026

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NEWS

Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

Shots: Health Canada has approved Yesintek Autoinjector (45 mg/0.05 mL & 90 mg/mL), a biosimilar version of Stelara (ustekinumab) Yesintek is indicated for the treatment of mod. to sev. plaque psoriasis in pts (≥6yrs.), active psoriatic arthritis in adults, mod. to sev. active Crohn’s disease & ulcerative colitis in adults Yesintek was previously approved as…
July 30, 2026

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Incyte
NEWS

Incyte Reports EC Approval of Opzelura (Ruxolitinib) Cream for Moderate Atopic Dermatitis

Shots: The EC has approved Opzelura (ruxolitinib) cream for the treatment of moderate atopic dermatitis in adults for whom topical corticosteroids (TCSs) & topical calcineurin inhibitors (TCIs) are inadequate or inappropriate Approval was based on the P-IIIb (TRuE-AD4) study assessing Opzelura vs vehicle in 241 adults with moderate AD, which met its co-1EPs of EASI75…
July 29, 2026

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