Key Outcomes:
- ENFLONSIA (Merck) – EU approved for infant RSV prevention (single-dose injection)
- Blenrep combo (GSK) – China approved for 2L+ multiple myeloma; 42% reduced death risk
- GAZYVA sBLA (Roche) – FDA accepted for SLE; decision expected Dec 2026
- TZIELD (Sanofi) – FDA expanded to infants aged 1+ for early-stage T1D delay
- Coartem Baby (Novartis) – WHO prequalified; first-ever malaria treatment for newborns (2-5 kg)
- Breztri Aerosphere (AstraZeneca) – FDA approved for asthma (ages 12+); triple-combo inhaler
- POHERDY (Organon/Henlius) – EU’s first pertuzumab biosimilar for HER2+ breast cancer
- PLUVICTO (Novartis) – EU application withdrawn for pre-chemo mCRPC after CHMP concerns on study design
- Eli Lilly acquires Ajax Therapeutics for up to $2.3B; gains novel JAK2 inhibitor (AJ1-11095) for blood cancers
- OPKO Health takes 15% stake in Nicoya Therapeutics to expand RAYALDEE in Greater China
April 17, 2026
EU Expands Infant RSV Protection with ENFLONSIA Approval
Merck has received EU approval for ENFLONSIA (clesrovimab), administered as a single 105 mg IM dose, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. This approval marks a significant expansion beyond its earlier authorization in the U.S. The decision is supported by data from the pivotal P2b/3 CLEVER and P3 SMART studies. Safety outcomes were consistent with other monoclonal antibodies in this class, with most adverse events being mild, including injection-site reactions and rash. With this decision, ENFLONSIA becomes an additional EU option alongside existing preventive strategies, such as maternal vaccination or other monoclonal antibodies, to protect infants during their first RSV season.
Source: Merck PR Apr 17, 2026
April 20, 2026
NMPA Approves Blenrep Combo in China for 2L+ Multiple Myeloma
NMPA (China) has approved Blenrep (belantamab mafodotin) + BVd to treat adult patients with r/r MM (2L+). The approval follows priority review and BTD and is supported by results from the P3 DREAMM-7 study. The Blenrep combination showed a 42% reduction in risk of death and nearly tripled mPFS and OS vs the DVd regimen, while maintaining a safety and tolerability profile consistent with the known effects of the individual drugs. GSK noted that this approval brings an effective anti-BCMA option to 2L+ MM patients in China, with Blenrep offering a differentiated approach and convenient outpatient administration without complex pre-treatment or hospitalization.
Source: GSK PR Apr 20, 2026
April 21, 2026
FDA Accepts Roche’s GAZYVA/GAZYVARO sBLA in SLE Backed by Positive P3 ALLEGORY Data
U.S. FDA has accepted Roche’s sBLA for GAZYVA/GAZYVARO (obinutuzumab) in systemic lupus erythematosus (SLE), supported by positive P3 ALLEGORY study data showing a significant improvement in SRI-4 at 52 wks. A regulatory decision is expected by Dec 2026. The therapy is already approved in the US and EU for lupus nephritis, and the data were presented at SLEuro 2026 and published in the NEJM in Mar’26. GAZYVA/GAZYVARO outperformed placebo across all key secondary endpoints, improving BICLA response rates, enabling sustained steroid reduction, and significantly lowering flare risk (HR: 0.58; p=0.002). A relevant finding is that flares can lead to permanent organ damage (The median time to 1st flare could not be estimated.)
Efficacy Results at 52 wk:
Additional Information: ALLEGORY is one of four positive P3 studies supporting Gazyva/Gazyvaro in immune-mediated diseases, alongside REGENCY in lupus nephritis, INShore in idiopathic nephrotic syndrome, and MAJESTY in primary membranous nephropathy.
Source: Roche PR Apr 21, 2026
April 22, 2026
TZIELD Approval Expanded to Infants; Further FDA Review Ongoing in Stage 3 T1D
The U.S. FDA has approved an update for TZIELD, allowing it to be used in children (aged 1+; earlier it was only for ages 8+). It is used in patients with early-stage (stage 2) T1D to help delay the progression to full disease (stage 3). This approval was granted under priority review and is based on 1-year results from the P4 PETITE-T1D study. TZIELD is also being reviewed by the U.S. FDA for use in patients aged 8+ years who have recently developed stage 3 T1D to see if it can help slow down the disease progression. TZIELD is approved in multiple regions, including the EU (TEIZEILD), the UK, China, Canada, Israel, Saudi Arabia, the UAE, Kuwait, and Brazil, for delaying the progression to stage 3 T1D diabetes in adults and children aged 8+ years with stage 2 disease, while reviews in other markets are still underway. It has also received both BTD and ODD from the U.S. FDA.
Source: Sanofi PR Apr 22, 2026
April 24, 2026
WHO Prequalifies Novartis’s Coartem Baby, First Malaria Treatment for Newborns
Novartis reported that the WHO has prequalified Coartem Baby (Riamet Baby in some countries), the first malaria treatment specifically designed for newborns and infants weighing 2-5 kg. Developed by Novartis with scientific and financial support from Medicines for Malaria Venture (MMV), as part of the PAMAfrica consortium, which is co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency. WHO prequalification is a process that evaluates the quality, safety, and effectiveness of treatments, and its approved product lists help the United Nations (UN) and other agencies make public sector funding and purchasing decisions. Novartis plans to provide it on a largely not-for-profit basis in malaria-affected regions, with initial rollout already started in Ghana.
Source: Novartis PR Apr 24, 2026
April 24, 2026
Novartis Withdraws EU Application for PLUVICTO in Pre-Chemo mCRPC After CHMP Feedback
Novartis has decided to withdraw its type II variation application to the EMA for expanding the use of PLUVICTO in patients with PSMA-positive mCRPC before CT, following feedback from CHMP. The committee raised concerns about the design of the P3 PSMAfore study, particularly the control arm used. This decision is not related to any concerns about the drug’s safety or effectiveness and does not impact its ongoing studies or existing approvals. PLUVICTO remains approved for mCRPC use in the U.S., Japan, and China, and its benefit is supported by recommendations from major oncology clinical guidelines.
Source: Novartis PR Apr 24, 2026
April 28, 2026
AstraZeneca Expands Breztri Aerosphere into Asthma with Strong P3 Data
AstraZeneca has received U.S. FDA approval for Breztri Aerosphere as a maintenance treatment for asthma in patients aged 12+ years. It is a single inhaler that combines 3 types of medicines (ICS/LABA + LAMA) to help control asthma. The approval is supported by P3 KALOS study and LOGOS study data, which showed significant improvement in lung function compared to dual ICS/LABA therapy and, in key secondary endpoints, demonstrated a rapid onset of action with noticeable lung function improvement within 5 minutes of the first dose. However, it is intended for maintenance treatment and not for immediate relief or use as a rescue inhaler. Results were published in The Lancet Respiratory Medicine in Feb 2026, with no new safety or tolerability concerns observed for Breztri Aerosphere. This single-inhaler, fixed-dose triple therapy is already approved for treating COPD in adults across 90 countries, including the U.S., EU, China, and Japan, while regulatory submissions for its use in asthma are currently being reviewed in several major markets worldwide.
Source: AstraZeneca PR Apr 28, 2026
April 29, 2026
EC Approves POHERDY, Europe’s First Pertuzumab Biosimilar for HER2+ Breast Cancer
The EC has approved POHERDY (pertuzumab), developed by Shanghai Henlius Biotech and commercialized by Organon, marking the 1st and only biosimilar to Perjeta (pertuzumab) 420 mg/14 mL in the EU for all its approved indications. This IV therapy is used in combination regimens to treat HER2-positive breast cancer across early and metastatic settings, and the approval was supported by comprehensive analytical, PK, and clinical data demonstrating high similarity in efficacy, safety, and immunogenicity to the reference product. The milestone is expected to expand patient access and improve the affordability of biologic cancer treatments in EU.
April 16, 2026
Faron Partners with Parexel for Global P2b BEXERA Study in Higher-Risk MDS
Faron Pharmaceuticals has partnered with Parexel International, a global CRO, to support its upcoming P2b BEXERA study (FP2CLI012) to treat patients with naïve higher-risk MDS. The study is a randomized, double-blind, placebo-controlled study evaluating bexmarilimab + azacitidine at 1 mg/kg and 3 mg/kg vs placebo + azacitidine. Set to launch in H2 2026, the study will enroll approximately 90 pts across North American and European sites. Its primary goals are to identify the recommended P3 dose and establish efficacy and safety data to support future registrational filings in frontline HR-MDS.
Source: Faron Pharmaceuticals PR Apr 16, 2026
April 27, 2026
Eli Lilly Acquires Ajax for AJ1-11095
Eli Lilly acquired Ajax Therapeutics to advance next-generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs) & polycythemia vera (PCV) and lead assets, AJ1-11095, a FIC, QD, oral Type II JAK2 inhibitor currently in P1 study, which is designed to deliver deeper and more durable responses compared to existing Type I JAK inhibitors that often lose effectiveness over time. The deal, valued at up to $2.3B, includes an upfront payment along with additional milestone-based payments tied to clinical and regulatory achievements. By acquiring Ajax, Lilly aims to strengthen its hematology and oncology pipeline, leveraging its expertise in blood cancers to advance innovative treatments and address unmet needs in patients who have limited long-term benefit from current therapies.
Source: Eli Lilly PR Apr 27, 2026
April 30, 2026
OPKO Health Takes 15% Stake in Nicoya Therapeutics to Expand RAYALDEE in China
OPKO Health has revised its agreement with Nicoya Therapeutics through its subsidiary EirGen Pharma Limited, taking a 15% equity stake in Nicoya in exchange for changes to royalties and transfer pricing. The updated deal keeps the original milestone structure intact, with OPKO still eligible for up to $115M, and broadens the scope of use while maintaining Nicoya’s role in commercializing RAYALDEE in Greater China. The drug is already approved in Macau, with potential approvals in China and nearby regions expected around 2027. The partnership, first signed in 2021, focuses on using RAYALDEE to treat secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease. RAYALDEE is an extended-release form of calcifediol (a vitamin D3 precursor) and has been marketed in the U.S. since 2016. OPKO will continue manufacturing and supplying it.
Source: OPKO PR Apr 30, 2026
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Babli Singh is a Senior Analyst with strong analytical skills and a deep understanding of the biopharmaceutical and healthcare industries. She specializes in monitoring emerging trends and distilling complex information into concise, insightful summaries that deliver clear value and actionable intelligence for a global professional audience.
