Sun Pharma Launches Unloxcyt (Cosibelimab-ipdl) for the Treatment of aCSCC

Shots: Sun Pharma has reported Unloxcyt (cosibelimab-ipdl) is now available in the US for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not eligible for curative surgery or radiation Approval of label update was based on long-term pivotal CK-301-101 data, showing improved ORR, including higher CR, and DoR without new…

ByDipanshu DixitJanuary 16, 2026

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Sanofi’s Teizeild (Teplizumab) Receives the EC Approval to Delay Progression of Type 1 Diabetes

Shots: The EC has approved Sanofi's Teizeild (Tzield outside the EU) to delay the onset of stage 3 type 1 diabetes (T1D) in adult & pediatric pts (≥8yrs.) with stage 2 T1D; regulatory review is ongoing in the other regions Approval was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32)…

ByRidhi RastogiJanuary 12, 2026

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Johnson & Johnson Reports Topline P-IIb (JASMINE) Trial Data on Imaavy (Nipocalimab) for Systemic Lupus Erythematosus (SLE)

Shots: J&J has reported the topline P-IIb (JASMINE) trial data assessing Imaavy (nipocalimab) vs PBO in 228 adults with SLE, along with the initiation of the P-III program Trial met its 1EP with higher SRI-4 composite response at Wk. 24, plus achieved secondary & exploratory endpoints, incl. those indicating the potential of nipocalimab for steroid sparing;…

ByRidhi RastogiJanuary 7, 2026

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

Shots: The Chinese NMPA has approved Nucala as an add-on maintenance treatment of adults with inadequately controlled COPD characterised by eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA filing is under review MATINEE assessed Nucala (100mg, SC, Q4W) vs PBO in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…

ByRidhi RastogiJanuary 5, 2026

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HUTCHMED Initiates P-III Trial of Surufatinib + Camrelizumab + CT for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Shots: HUTCHMED has initiated P-III portion of P-II/III trial of the combination of surufatinib, camrelizumab, nab-paclitaxel & gemcitabine (S+C+AG) as the 1L treatment of metastatic PDAC in China, with the first patient receiving the dose on Dec 30, 2025 Trial will evaluate the combination against nab-paclitaxel + gemcitabine in ~400 PDAC adults who have not…

ByRidhi RastogiJanuary 5, 2026

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Elanco Animal Health Reports the USDA Approval of Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis

Shots: The USDA has granted Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis, expected to launch in H1’26 Befrena (mAb) is an anti-IL31 injection for dogs, treats allergic and atopic dermatitis every 6–8 wks. In September, the FDA approved changes to Zenrelia (ilunocitinib tablets) US label, eliminating the fatal vaccine-induced disease risk, Elanco announced Ref:…

ByDipanshu DixitJanuary 1, 2026

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Windward Bio Secures Exclusive Rights to WIN027 from Qyuns Therapeutics in a ~$700M Deal

Shots: Windward Bio via its affiliate, LE2025 Therapeutics, has entered into a licensing agreement with Qyuns to develop & commercialize WIN027 (QX027N; anti-TSLPxIL-13 bsAb) As per the deal, Windward will obtain exclusive rights to develop, manufacture, & commercialize WIN027 outside of China, with Qyuns receiving an upfront payment, equity, & development, regulatory, & commercial milestones,…

ByRidhi RastogiDecember 24, 2025

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Amneal Pharmaceuticals and mAbxience’s Boncresa and Oziltus (Biosimilar, Prolia and Xgeva) Receive the US FDA’s Approval

Shots: The US FDA has approved Boncresa (denosumab-mobz), a biosimilar version of Prolia, and Oziltus (denosumab-mobz), a biosimilar version of Xgeva Denosumab is an mAb that reduces bone resorption and is used in oncology and osteoporosis indications Under the Amneal and mAbxience collaboration, mAbxience manages development and manufacturing, and Amneal has exclusive US commercialization rights Ref: Amneal Pharmaceuticals| Image: Amneal Pharmaceuticals and mAbxience | Press Release Related News:- Kashiv BioSciences and Amneal…

ByDipanshu DixitDecember 22, 2025

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Shanghai Henlius Receives the US FDA IND Clearance for HLX18 (Biosimilar, Opdivo)

Shots: The US FDA has granted IND clearance to HLX18 (nivolumab), a biosimilar version of Opdivo, for the treatment of certain resected solid tumors Novolumab is an 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 HLX17 (pembrolizumab biosimilar) and HLX13 (ipilimumab biosimilar) have entered worldwide multicenter P-I…

ByDipanshu DixitDecember 19, 2025

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Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the CHMP Positive Opinion for Multiple Immune-Mediated Diseases

Shots: The CHMP has recommended Celltrion's Steqeyma autoinjector (45mg/0.5mL & 90mg/1mL), a biosimilar version of Stelara (ustekinumab), for the treatment of pts with plaque psoriasis, psoriatic arthritis (PsA) & Crohn’s disease (CD) SteQeyma (CT-P43) is a human anti-IL-12 & IL-23 monoclonal antibody that is also available in SC formulation (45mg/0.5 mL or 90mg/1 mL in…

ByRidhi RastogiDecember 18, 2025

Sun Pharma Launches Unloxcyt (Cosibelimab-ipdl) for the Treatment of aCSCC

Sanofi’s Teizeild (Teplizumab) Receives the EC Approval to Delay Progression of Type 1 Diabetes

Johnson & Johnson Reports Topline P-IIb (JASMINE) Trial Data on Imaavy (Nipocalimab) for Systemic Lupus Erythematosus (SLE)

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

HUTCHMED Initiates P-III Trial of Surufatinib + Camrelizumab + CT for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Elanco Animal Health Reports the USDA Approval of Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis

Windward Bio Secures Exclusive Rights to WIN027 from Qyuns Therapeutics in a ~$700M Deal

Amneal Pharmaceuticals and mAbxience’s Boncresa and Oziltus (Biosimilar, Prolia and Xgeva) Receive the US FDA’s Approval

Shanghai Henlius Receives the US FDA IND Clearance for HLX18 (Biosimilar, Opdivo)

Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the CHMP Positive Opinion for Multiple Immune-Mediated Diseases

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