STADA & Bio-Thera Receive the CHMP Positive Opinion for Gotenfia (Biosimilar, Simponi)

Shots: The CHMP has recommended STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), for EC approval valid in all 30 EEA states Opinion was based on extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects, plus P-III…

ByRidhi RastogiDecember 12, 2025

NEWS

BMS Reports the US FDA’s sBLA Acceptance with Priority Review of Opdivo for Classical Hodgkin Lymphoma (cHL)

Shots: The US FDA has accepted sBLA & granted priority review to BMS' Opdivo (nivolumab) + doxorubicin, vinblastine & dacarbazine (AVD) for the treatment of pts (≥12yrs.) with previously untreated Stage III or IV cHL (PDUFA: Apr 8, 2026) sBLA was supported by the P-III (SWOG S1826/ CA2098UT) trial assessing Opdivo + AVD in above…

ByRidhi RastogiDecember 12, 2025

NEWS

The US FDA Approves Amgen’s Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis

Shots: The US FDA has approved Amgen's Uplizna for the treatment of AChR & MuSK antibody positive adults with generalized myasthenia gravis (gMG) Approval was based on P-III (MINT) trial in 238 adults with gMG (190 AChR+, 48 MuSK+), where pts received 2 Uplizna loading dose followed by 2 doses/year; pts on steroids began tapering…

ByRidhi RastogiDecember 12, 2025

NEWS

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

GSK’s Risvutatug Rezetecan Secures the US FDA’s Orphan Drug Designation for Treating SCLC

Shots: The US FDA has granted ODD to GSK’s risvutatug rezetecan (GSK5764227) for the treatment of small-cell lung cancer (SCLC) Designation was supported by preliminary P-I (ARTEMIS-001) trial data showing durable responses in pts with extensive-stage SCLC treated with risvutatug rezetecan GSK’227 is a B7-H3-targeted ADC developed by Hansoh Pharma for various solid tumors. GSK…

ByRidhi RastogiDecember 11, 2025

NEWS

PTC Therapeutics Receives the Health Canada Approval for Sephience to Treat Phenylketonuria

Shots: Health Canada has approved PTC's Sephience (sepiapterin) for the treatment of phenylketonuria (PKU) in pts of all ages, with broad labeling for hyperphenylalaninemia in pts (≥1mos.) with sepiapterin-responsive PKU Approval was based on APHENITY study results & long-term extension data showing durable effects & favorable safety in PKU pts Sephience is a natural precursor…

ByRidhi RastogiDecember 11, 2025

NEWS

Zealand Pharma Inks ~$2.5B Deal with OTR Therapeutics to Discover and Develop Metabolic Disease Therapies

Shots: Zealand Pharma has entered into a multi-program strategic collaboration & license agreement with OTR to discover & develop oral small molecules for metabolic diseases OTR & Zealand will jointly discover & develop multiple metabolic disease therapies, with OTR using its discovery platform to lead discovery & preclinical work while Zealand will handle global clinical…

ByRidhi RastogiDecember 11, 2025

NEWS

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

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

Ridhi Rastogi

STADA & Bio-Thera Receive the CHMP Positive Opinion for Gotenfia (Biosimilar, Simponi)

BMS Reports the US FDA’s sBLA Acceptance with Priority Review of Opdivo for Classical Hodgkin Lymphoma (cHL)

The US FDA Approves Amgen’s Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis

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)

GSK’s Risvutatug Rezetecan Secures the US FDA’s Orphan Drug Designation for Treating SCLC

PTC Therapeutics Receives the Health Canada Approval for Sephience to Treat Phenylketonuria

Zealand Pharma Inks ~$2.5B Deal with OTR Therapeutics to Discover and Develop Metabolic Disease Therapies

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

Contact US

FOLLOW US