Eli Lilly Reports P-III (TRIUMPH-4) Trial Data on Retatrutide for Weight Management

Shots: Trial assessed Lilly’s retatrutide (9 & 12mg) + lifestyle intervention in adults with obesity or overweight & knee osteoarthritis, & without diabetes, meeting its co-1EPs with 26.4% (9mg) & 28.7% (12mg) vs 2.1% weight loss & reduced WOMAC pain by 4.5 & 4.4 vs 2.4 points It also reduced known CV risk markers &…

ByRidhi RastogiDecember 12, 2025

NEWS

GSK Reports the US FDA Approval of Blujepa for Uncomplicated Urogenital Gonorrhoea (uGC)

Shots: The US FDA has approved GSK's Blujepa (gepotidacin) for the treatment of pts (≥12yrs.; ≥45kg) with uGC caused by Neisseria gonorrhoeae who have limited or no alternative options for treatment Approval was backed by P-III (EAGLE-1) trial assessing Blujepa (2 doses × 3000mg; PO) vs ceftriaxone (500mg; IM) + azithromycin (1000mg; PO) in ~600 pts with…

ByRidhi RastogiDecember 12, 2025

NEWS

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

Shots: Roche 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 At the interim analysis, trial met its 1EP of improved invasive disease-free survival (iDFS) by 30%, with 92.4% vs 89.6% pts alive & invasive disease free…

ByRidhi RastogiDecember 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

Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Shots: Eli Lilly has reported P-III (BRUIN CLL-313) trial data assessing Jaypirca (pirtobrutinib; 200mg, PO, QD; n=141) vs bendamustine + rituximab (n=141) in 282 treatment-naïve CLL/SLL pts without 17p deletions As of Jul 11, 2025, trial met its 1EP of improved IRC-assessed PFS by 80% with benefits seen across all high-risk subgroups & investigator assessments at…

ByRidhi RastogiDecember 10, 2025

NEWS

Capricor Therapeutics Reports the Topline P-III (HOPE-3) Trial Data on Deramiocel for Duchenne Muscular Dystrophy

Shots: Capricor Therapeutics has reported the topline P-III (HOPE-3) trial data assessing Deramiocel (IV, Q3M) vs PBO in boys & young men (n=106) with DMD for 12mos. across the US Trial met its 1EP with a 54% slowing of upper-limb functional decline (PUL v2.0) among 105 evaluable pts at 12mos. & achieved its 2EP with…

ByRidhi RastogiDecember 4, 2025

NEWS

Iolyx Therapeutics Enters a Strategic Deal with Laboratoires Théa for ILYX-002 to Treat Ocular Surface Conditions

Shots: Iolyx has granted Théa exclusive global rights (excl. Asia) to develop & commercialize ILYX-002 for Dry Eye Disease associated with systemic autoimmune disorders & other ocular surface conditions Iolyx will receive ~$280M in clinical, regulatory, & commercial milestones; tiered royalties up to ~21%; & R&D cost reimbursement. Iolyx will design P-III trials, handle manufacturing,…

ByRidhi RastogiDecember 4, 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

Eli Lilly Reports P-III (TRIUMPH-4) Trial Data on Retatrutide for Weight Management

GSK Reports the US FDA Approval of Blujepa for Uncomplicated Urogenital Gonorrhoea (uGC)

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

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

Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Capricor Therapeutics Reports the Topline P-III (HOPE-3) Trial Data on Deramiocel for Duchenne Muscular Dystrophy

Iolyx Therapeutics Enters a Strategic Deal with Laboratoires Théa for ILYX-002 to Treat Ocular Surface Conditions

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

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