Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)

Shots: The US FDA has approved Sanofi's Tzield (teplizumab-mzwv), under priority review, to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D Approval was supported by 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of Tzield (IV, QD for 14 consecutive days) in…

ByRidhi RastogiApril 22, 2026

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Akeso Announces P-II (COMPASSION-26) Trial Results on Cadonilimab + CT in 1L PDAC

Shots: Akeso has reported the P-II (COMPASSION-26) trial results assessing cadonilimab + CT as the 1L treatment of advanced pancreatic ductal adenocarcinoma (PDAC) As of Oct 20, 2025 (mFU of >2yrs.), trial showed robust & durable survival benefits, with mPFS of 11.1mos. & mOS of >23mos., showing 12 & 24mos. OS rate of 91.7% &…

ByRidhi RastogiApril 21, 2026

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Apogee Therapeutics Reports Part A P-II (APEX) Maintenance Data on Zumilokibart in Atopic Dermatitis

Shots: Apogee has reported maintenance data from Part A of the P-II (APEX) trial assessing zumilokibart (APG777; 360mg at Q3M or Q6M) in pts with mod. to sev. atopic dermatitis Trial showed 75% (Q3M) & 85% (Q6M) of Wk. 16 zumilokibart-responders maintained EASI-75, while 86% (Q3M) & 78% (Q6M) sustained vIGA 0/1, with continued deepening…

ByRidhi RastogiMarch 24, 2026

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Samsung Bioepis Partners with Sandoz for Up to Five Biosimilar Candidates

Shots: Samsung Bioepis has entered into a global license, development & commercialization agreement with Sandoz for up to five biosimilars, incl. SB36 (preclinical), a biosimilar version of Entyvio (vedolizumab) Samsung Bioepis will handle development, manufacturing & regulatory filings, while Sandoz will lead commercialization globally (excl. China, Hong Kong, Taiwan, Macau & Republic of Korea) The…

ByRidhi RastogiMarch 18, 2026

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Celltrion Introduces Avtozma SC (Biosimilar, Actemra) in the US

Shots: Celltrion launched Avtozma SC, a biosimilar to Actemra (tocilizumab), in the US, becoming among the first to offer both IV & SC formulations approved by the US FDA & available in the market Avtozma received the FDA & EC approval in Jan & Feb 2025, respectively, based on a global P-III trial showing comparable…

ByRidhi RastogiMarch 17, 2026

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Genentech Reports P-III (MAJESTY) Trial Results for Gazyva in Primary Membranous Nephropathy

Shots: Genentech has reported the P-III (MAJESTY) trial results assessing Gazyva vs tacrolimus in 142 pts with primary membranous nephropathy Trial met its 1EP, showing higher CR at Wk. 104 & achieved its key 2EPs, incl. improved overall remission & CR at Wks. 104 & 76, respectively; data to be presented in the future &…

ByRidhi RastogiFebruary 16, 2026

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Lundbeck Reports Topline P-IIb (PROCEED) Trial Results on Bocunebart in Migraine Prevention

Shots: Lundbeck has reported P-IIb (PROCEED) trial results evaluating bocunebart (SC/IV; QM for 3mos.) vs PBO in migraine patients with prior failure of 1-4 preventive therapies, with the IV arm randomizing 431 pts across 14 countries Trial met its 1EP in the multiple IV dosing arm, showing a statistically significant reduction in monthly migraine days…

ByRidhi RastogiFebruary 16, 2026

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GSK Reports the EC Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The EC has approved Nucala as an add-on maintenance treatment of adults with uncontrolled COPD characterised by raised blood eosinophils phenotype on a combination of an inhaled corticosteroid, a long-acting beta2-agonist (LABA), & a long-acting muscarinic antagonist Approval was based on the P-III (MATINEE) trial assessing Nucala (100mg, SC, Q4W; n=403) vs PBO (n=401)…

ByRidhi RastogiFebruary 6, 2026

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Zydus Lifesciences Launches Tishtha (Biosimilar, Opdivo) in India

Shots: Zydus Lifesciences has reported Tishtha, biosimilar version of Opdivo (Nivolumab), is now available in the India Tishtha will be available in 100 mg and 40 mg strengths Nivolumab is a mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma Ref: Zydus | Image: Zydus | Press Release Related News: Shanghai Henlius Receives the US FDA…

ByDipanshu DixitJanuary 22, 2026

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Akeso Reports the NMPA’s sNDA Acceptance of Gumokimab for Active Ankylosing Spondylitis

Shots: The Chinese NMPA has accepted the sNDA of gumokimab for the treatment of active ankylosing spondylitis (AS) sNDA was backed by the P-III (AK111-303) trial in AS, which met all efficacy endpoints, with 1EP (ASAS20 response rate) showing consistent improvements across subgroups, along with 2EP (ASAS40 response rate) & gumokimab delivering rapid symptom relief…

ByRidhi RastogiJanuary 20, 2026

Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)

Akeso Announces P-II (COMPASSION-26) Trial Results on Cadonilimab + CT in 1L PDAC

Apogee Therapeutics Reports Part A P-II (APEX) Maintenance Data on Zumilokibart in Atopic Dermatitis

Samsung Bioepis Partners with Sandoz for Up to Five Biosimilar Candidates

Celltrion Introduces Avtozma SC (Biosimilar, Actemra) in the US

Genentech Reports P-III (MAJESTY) Trial Results for Gazyva in Primary Membranous Nephropathy

Lundbeck Reports Topline P-IIb (PROCEED) Trial Results on Bocunebart in Migraine Prevention

GSK Reports the EC Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Zydus Lifesciences Launches Tishtha (Biosimilar, Opdivo) in India

Akeso Reports the NMPA’s sNDA Acceptance of Gumokimab for Active Ankylosing Spondylitis

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