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…

December 12, 2025

LIB Therapeutics Receives the FDA Approval for Lerochol (Lerodalcibep-liga) for Adults with Elevated LDL Cholesterol

Shots: The US FDA has approved Lerochol as an LDL-C lowering therapy for adults with hypercholesterolemia, including HeFH; US launch as a PFS is expected in spring 2026, with an autoinjector later in 2026, while EMA approval is anticipated in Jun 2026 alongside additional global regulatory filings Approval was supported by the global P-III (LIBerate) trial, enrolling over 2,900 CVD patients and without…

December 12, 2025

Innoviva Specialty Therapeutics Receives the FDA Approval for Nuzolvence (Zoliflodacin) for Uncomplicated Urogenital Gonorrhea

Shots: The US FDA has approved Nuzolvence for the treatment of uncomplicated urogenital gonorrhea in pts (age ≥12yrs.; Wt.≥35 kg), with US commercialization planned for the H2’26 Approval was based on a pivotal P-III multinational trial (n=930) evaluating a single 3g oral dose of Nuzolvence vs ceftriaxone (500 mg IM) + azithromycin (1 g oral) for uncomplicated urogenital gonorrhea, which demonstrated non-inferiority, comparable tolerability…

December 12, 2025

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…

December 12, 2025

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 &…

December 12, 2025

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

NEWS

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

LIB Therapeutics Receives the FDA Approval for Lerochol (Lerodalcibep-liga) for Adults with Elevated LDL Cholesterol

Innoviva Specialty Therapeutics Receives the FDA Approval for Nuzolvence (Zoliflodacin) for Uncomplicated Urogenital Gonorrhea

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

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

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