Lumos Labs Reports the US FDA Clearance of LumosityRx for ADHD Patients

Shots: The US FDA has granted 510(k) clearance to LumosityRx, a prescription digital therapeutic, designed to improve attention in adults (22-55yrs.) with attention deficit hyperactivity disorder (ADHD) Assessed in the GAMES Study (n>500), LumosityRx showed significantly improved TOVA Attention Comparison Score (1EP) vs a control app, with 44.2% pts achieving clinically meaningful attention gains (>1.4 points…

ByRidhi RastogiDecember 11, 2025

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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

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Formation Bio Licenses Lynk Pharmaceuticals’ LNK01006 to Expand its Immunology Pipeline

Shots: Lynk Pharmaceuticals has entered into an exclusive development & licensing agreement with Formation Bio, granting the latter worldwide rights to LNK01006 (excl. Greater China), a highly selective TYK2 inhibitor LNK01006 will be developed by Formation’s new subsidiary, Bleecker Bio, following recent US FDA IND clearance, with a P-I trial planned to start in the…

ByRidhi RastogiDecember 11, 2025

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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

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Novartis and Relation Therapeutics Ink ~$1.75B Atopic Disease Target-Discovery Alliance

Shots: Relation has entered into a multi-program, strategic collaboration with Novartis to identify & advance novel targets for atopic diseases, leveraging Relation’s Lab-in-the-Loop platform As per the deal, Relation will lead patient-derived observational studies to create high-resolution functional cell atlases, while Novartis will secure global development & commercialization rights to any resulting targets In return,…

ByRidhi RastogiDecember 10, 2025

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ProVerum Receives the US FDA Approval for ProVee System to Treat Benign Prostatic Hyperplasia

Shots: The US FDA has approved ProVee System for the treatment of benign prostatic hyperplasia (BPH) Approval was backed by the ProVIDE study assessing ProVee in men, which met its 1 & 2EPs, showing significant & durable symptom relief as well as improved urinary flow through 12mos. compared to sham, with preserved sexual function &…

ByRidhi RastogiDecember 10, 2025

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Formycon Partners with Zydus to Commercialize FYB206 (Biosimilar, Keytruda) in the US and Canada

Shots: Formycon has entered into an exclusive licensing & supply agreement with Zydus Lifesciences Global FZE, UAE (Zydus' subsidiary) to commercialize Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the US & Canada As per the deal, Formycon will be responsible for development, registration, manufacturing & supply of the product, while Zydus Lifesciences…

ByRidhi RastogiDecember 10, 2025

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Pfizer Collaborates with YaoPharma in a ~$2.1B Licensing Deal for YP05002

Shots: Pfizer has entered into an exclusive global collaboration & license agreement with YaoPharma for YP05002, a GLP-1 receptor agonist for chronic weight management As per the deal, YaoPharma will complete the ongoing P-I trial of YP05002 & grant Pfizer exclusive global rights for further development, manufacturing & commercialization, receiving $150M upfront & ~$1.935B in…

ByRidhi RastogiDecember 10, 2025

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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

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

Ridhi Rastogi

Lumos Labs Reports the US FDA Clearance of LumosityRx for ADHD Patients

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

Formation Bio Licenses Lynk Pharmaceuticals’ LNK01006 to Expand its Immunology Pipeline

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

Novartis and Relation Therapeutics Ink ~$1.75B Atopic Disease Target-Discovery Alliance

ProVerum Receives the US FDA Approval for ProVee System to Treat Benign Prostatic Hyperplasia

Formycon Partners with Zydus to Commercialize FYB206 (Biosimilar, Keytruda) in the US and Canada

Pfizer Collaborates with YaoPharma in a ~$2.1B Licensing Deal for YP05002

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

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

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