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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…
December 11, 2025

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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…
December 11, 2025

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Moderna
NEWS

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

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Boehringer Ingelheim
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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…
December 10, 2025

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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…
December 8, 2025

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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…
December 5, 2025

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Eli lilly
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…
December 4, 2025

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