NEWS

Genmab and AbbVie Report the US FDA Approval of Epkinly to Treat R/R Follicular Lymphoma

Shots: The US FDA has approved Epkinly (epcoritamab-bysp) + rituximab & lenalidomide (R2) for the treatment of adults with r/r follicular lymphoma (FL) & converted accelerated approval of Epkinly monotx. to full approval for r/r FL following ≥2L of systemic therapy Approval was based on P-III (EPCORE FL-1) trial assessing Epkinly + R2 (n=243)vs R2 alone(n=245)in…

November 19, 2025

The US FDA Receives Celcuity’s NDA for Gedatolisib to Treat Advanced Breast Cancer

Shots: The US FDA has received an NDA of gedatolisib under the RTOR program for the treatment of HR+, HER2-, advanced breast cancer NDA was supported by data from PIK3CA wild-type cohort of the P-III (VIKTORIA-1) study assessing gedatolisib + fulvestrant ± palbociclib vs fulvestrant in HR+/HER2- advanced breast cancer pts Trial showed that gedatolisib…

November 18, 2025

Genentech (Roche) Reports Interim P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer

Shots: Genentech has reported P-III (lidERA Breast Cancer) trial assessing giredestrant (QD) vs SoC endocrine therapy in pts (n=~4,100) with medium or high-risk stage I-III ER+, HER2- breast cancer Trial met its 1EP of improved invasive disease-free survival & showed a favorable OS trend; OS data remains immature. Results to be presented in future meetings…

November 18, 2025

Merus Partners with Halozyme to Develop Subcutaneous Petosemtamab

Shots: Merus has entered into a global non-exclusive collaboration and license agreement with Halozyme Therapeutics to develop & commercialize SC formulation of petosemtamab using Halozyme's Enhanze drug delivery technology As per the deal, Halozyme will receive an upfront, along with commercial & sales milestones payments, plus up to low-mid single-digit royalties; Although the financial details…

November 18, 2025

Celltrion Receives EC Approval for Remsima IV (Biosimilar, Remicade)

Shots: The EC has approved Remsima IV (100mg and 350mg vials), a liquid formulation, a biosimilar version of Remicade The approval is supported by data showing the liquid and powder infliximab formulations are comparable in CMC characteristics and stability after reconstitution and dilution The Remsima IV liquid formulation is EU-approved for all existing IV infliximab indications, including RA, adult and pediatric CD and UC,…

November 18, 2025

The EC Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

Shots: The EC has approved Omlyclo, a biosimilar version of Xolair (omalizumab), in PFS presentation (300 mg/2ml) for the treatment of pts with allergic asthma, chronic spontaneous urticaria (CSU) & chronic rhinosinusitis with nasal polyps (CRSwNP) Omlyclo previously received the EC approval in May 2024 for PFS injections at 75mg/0.5mL & 150mg/1mL Omalizumab is a…

November 18, 2025

Arcutis Biotherapeutics Reports the US FDA’s sNDA Acceptance of Zoryve (Roflumilast) to Treat Plaque Psoriasis (PsO) in Children

Shots: The US FDA has accepted the sNDA of Zoryve (0.3% roflumilast cream) for the treatment of children (2-5yrs.) with PsO (PDUFA: Jun 29, 2026) The sNDA is supported by a 4wk. MUSE study in children (2-5yrs.) with PsO & a long-term open-label study showing consistent favorable safety, tolerability, & sustained efficacy across all age…

November 18, 2025

J&J Accelerates Cancer Innovation with $3.05B Halda Therapeutics Acquisition

Shots: J&J has entered into a definitive agreement to acquire Halda Therapeutics, strengthening its oncology pipeline As per the deal, J&J will acquire Halda for $3.05B in cash, with the deal treated as a business combination & expected to close in the coming months Acquisition will add Halda’s Regulated Induced Proximity TArgeting Chimera (RIPTAC) platform…

November 18, 2025

Incyte’s Minjuvi Combination Gains the CHMP’s Positive Opinion for R/R Follicular Lymphoma (FL)

Shots: The CHMP has recommended Minjuvi (tafasitamab) + rituximab & lenalidomide for the treatment of adult pts with r/r FL (Grade 1-3a) who received ≥1L of systemic therapy Opinion was based on the P-III (inMIND) trial (N=654) assessing Minjuvi combination vs PBO + rituximab & lenalidomide in r/r FL (n=548) & r/r nodal, splenic or…

November 17, 2025

Sandoz Launches Tyruko (Biosimilar, Tysabri) in the US

Shots: Sandoz has launched Tyruko, a biosimilar version of Biogen’s Tysabri (natalizumab), for all indications of the reference product, incl. relapsing forms of multiple sclerosis (MS) & mod. to sev. active Crohn’s disease in adults In 2019, Sandoz signed a global commercialization deal with Polpharma for Tyruko, with Polpharma responsible for development & manufacturing of…

November 17, 2025

NEWS

Genmab and AbbVie Report the US FDA Approval of Epkinly to Treat R/R Follicular Lymphoma

The US FDA Receives Celcuity’s NDA for Gedatolisib to Treat Advanced Breast Cancer

Genentech (Roche) Reports Interim P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer

Merus Partners with Halozyme to Develop Subcutaneous Petosemtamab

Celltrion Receives EC Approval for Remsima IV (Biosimilar, Remicade)

The EC Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

Arcutis Biotherapeutics Reports the US FDA’s sNDA Acceptance of Zoryve (Roflumilast) to Treat Plaque Psoriasis (PsO) in Children

J&J Accelerates Cancer Innovation with $3.05B Halda Therapeutics Acquisition

Incyte’s Minjuvi Combination Gains the CHMP’s Positive Opinion for R/R Follicular Lymphoma (FL)

Sandoz Launches Tyruko (Biosimilar, Tysabri) in the US

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