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…

December 12, 2025

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…

December 11, 2025

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…

December 11, 2025

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…

December 11, 2025

Moderna Reports the CHMP Positive Opinion on mNEXSPIKE to Protect Against COVID-19

Shots: The CHMP has recommended mNEXSPIKE (mRNA-1283), a COVID-19 vaccine, for active immunization against SARS-CoV-2 in individuals (age≥12 yrs) Opinion was based on the P-III trial evaluating mNEXSPIKE (mRNA-1283; 10 µg) versus Spikevax (mRNA-1273; 50 µg) in ~11,400 participants (age ≥12 yrs), with primary efficacy assessed from 14 days post-vaccination The trial met its 1EP with mNEXSPIKE showing 9.3% superior relative vaccine efficacy (rVE) in subjects (≥12yrs.), whereas in…

December 11, 2025

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…

December 11, 2025

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…

December 11, 2025

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…

December 11, 2025

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…

December 11, 2025

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…

December 10, 2025

NEWS

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

Moderna Reports the CHMP Positive Opinion on mNEXSPIKE to Protect Against COVID-19

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

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

Contact US

FOLLOW US