ImmunityBio Reports EC’s Conditional Approval on Anktiva for BCG-Unresponsive Non-muscle Invasive Bladder Cancer (NMIBC)

Shots: The EMA has recommended conditional EU marketing authorization for Anktiva (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC carcinoma in situ. Recommendation was based on safety and efficacy data in 100 adults, showing a 71% CR rate, with responses lasting a median of ~27 mos and extending up to 54+ mos; CR rates among responders were 66% at…

ByDipanshu DixitDecember 11, 2025

NEWS

Boehringer Ingelheim Receives the NMPA Approval of Jascayd (Nerandomilast) for Progressive Pulmonary Fibrosis

Shots: The Chinese NMPA has approved Boehringer Ingelheim's Jascayd for the treatment of adults with progressive pulmonary fibrosis (PPF) Approval was based on the P-III (FIBRONEER-ILD) trial of Jascayd vs PBO, which met its 1EP of reduced FVC at Wk. 52 & showed a significant reduction in death risk Additionally, Jascayd'ssNDA for PPF is under…

ByRidhi RastogiDecember 10, 2025

NEWS

Junshi Biosciences Reports NMPA Acceptance of the NDA for Roconkibart (IL-17A) to Treat Moderate to Severe Plaque Psoriasis

Shots: Junshi Biosciences reported that the NMPA has accepted the NDA for roconkibart injection (JS005), for adults with moderate to severe plaque psoriasis eligible for systemic therapy or phototherapy The submission is backed by a multicenter P-III study (n=747) showing significant improvements in PASI 75/90/100 and sPGA 0/1 vs PBO at 12wks., with sustained efficacy…

ByPrince GiriDecember 8, 2025

NEWS

Hope Medicine’s HMI-115 Receives the US FDA Fast Track Designation for Endometriosis-Associated Pain Relief

Shots: The US FDA has granted FTD to HMI-115 for the treatment of mod. to sev. pain associated with endometriosis Designation was based on the global P-II dose-finding study assessing HMI-115 vs PBO for 12wks. in 108 females with surgically diagnosed endometriosis across the US, Poland & China, showing significant improvement Trial showed that HMI-115…

ByRidhi RastogiDecember 5, 2025

NEWS

BMS Reports the US FDA Approval of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Shots: The US FDA has approved Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with r/r MZL who have received ≥2L of systemic therapy Approval was supported by MZL cohort data from the P-II (TRANSCEND FL) trial assessing Breyanzi in pts with r/r indolent B-cell non-Hodgkin lymphoma incl. follicular lymphoma & MZL In…

ByRidhi RastogiDecember 5, 2025

NEWS

Eli Lilly’s Jaypirca Receives the FDA Approval for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Shots: The US FDA has approved label expansion of Jaypirca (pirtobrutinib; 100 & 50mg) for the treatment of adults with r/r CLL/SLL who were previously treated with a covalent BTK inhibitor & converted the accelerated approval of Dec 2023 to a full approval Label expansion was based on the P-III (BRUIN CLL-321) study assessing Jaypirca…

ByRidhi RastogiDecember 4, 2025

NEWS

Ionis’ Zilganersen Receives the US FDA’s Breakthrough Therapy Designation for Alexander Disease

Shots: The US FDA has granted BTD to zilganersen for the treatment of Alexander disease (AxD) Designation was supported by the topline P-III trial data, which assessed zilganersen (25 or 50mg) vs control in 54 AxD pts (1.5-53yrs.). Zilganersen (50mg) met the 1EP of gait speed as assessed by 10-Meter Walk Test at 61wks., plus…

ByRidhi RastogiDecember 3, 2025

NEWS

AstraZeneca Reports the US FDA’s NDA Acceptance with Priority Review of Baxdrostat for Hard-to-Control Hypertension

Shots: The US FDA has accepted NDA & granted priority review to Baxdrostat as an add-on treatment of pts with uncontrolled or treatment-resistant hypertension (PDUFA: Q2’26 following use of PRV) NDA was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with…

ByRidhi RastogiDecember 3, 2025

NEWS

Johnson & Johnson Reports the EC Approval of Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG)

Shots: The EC has approved Imaavy (nipocalimab) as an add-on therapy to treat anti-AChR or anti-MuSK antibody-positive gMG pts (≥12yrs.) Approval was based on the P-III (Vivacity-MG3) trial assessing Imaavy (30mg/kg, IV loading dose then 15mg/kg, Q2W) + SoC (n=77) vs PBO + SoC (n=76) in gMG pts (N=199; 153 were Ab +ve), which showed…

ByRidhi RastogiDecember 2, 2025

NEWS

Cosmo and Glenmark Reports the EC Approval on Winlevi to Treat Acne Vulgaris Across 17 countries in EU

Shots: The EC has approved Cosmo Pharmaceuticals and Glenmark Pharmaceuticals’ Winlevi (clascoterone 10 mg/g cream) for the Treatment of Acne Vulgaris in 17 countries in Europe Winlevi is authorized in the EU for treating acne vulgaris in adults and adolescents aged 12 to <18 years, with adolescent use limited to facial application Following approval, Glenmark will begin commercializing Winlevi across 17 European countries, including Belgium, France, Spain,…

ByDipanshu DixitDecember 1, 2025

ImmunityBio Reports EC’s Conditional Approval on Anktiva for BCG-Unresponsive Non-muscle Invasive Bladder Cancer (NMIBC)

Boehringer Ingelheim Receives the NMPA Approval of Jascayd (Nerandomilast) for Progressive Pulmonary Fibrosis

Junshi Biosciences Reports NMPA Acceptance of the NDA for Roconkibart (IL-17A) to Treat Moderate to Severe Plaque Psoriasis

Hope Medicine’s HMI-115 Receives the US FDA Fast Track Designation for Endometriosis-Associated Pain Relief

BMS Reports the US FDA Approval of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Eli Lilly’s Jaypirca Receives the FDA Approval for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Ionis’ Zilganersen Receives the US FDA’s Breakthrough Therapy Designation for Alexander Disease

AstraZeneca Reports the US FDA’s NDA Acceptance with Priority Review of Baxdrostat for Hard-to-Control Hypertension

Johnson & Johnson Reports the EC Approval of Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG)

Cosmo and Glenmark Reports the EC Approval on Winlevi to Treat Acne Vulgaris Across 17 countries in EU

Contact US

FOLLOW US