NEWS

X4 Pharmaceuticals’ Xolremdi (Mavorixafor) Receives the CHMP Positive Opinion for WHIM Syndrome

Shots: The CHMP has recommended approval of Xolremdi, under exceptional circumstances, for the treatment of WHIM syndrome, with EC’s decision expected in Q2’26 Opinion was backed by the global P-III (4WHIM) trial assessing Xolremdi vs PBO in 31 pts (≥12yrs.) with WHIM syndrome, which showed improved absolute lymphocyte counts, absolute neutrophil counts, & fewer infections,…

March 2, 2026

Ipsen Reports the CHMP Positive Opinion for Ojemda (Tovorafenib) for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG)

Shots: The CHMP has recommended conditional approval of Ojemda monotx. for the treatment of pts (≥6mos.) with pLGG harbouring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after ≥1 prior systemic therapy Opinion was based on the ongoing P-II (FIREFLY-1) trial assessing Ojemda (QW, PO) in 137 relapsed or refractory BRAF-altered pLGG…

March 2, 2026

GSK Reports the MHLW’s NDA Acceptance for Bepirovirsen to Treat Chronic Hepatitis B

Shots: The Japanese MHLW has accepted the NDA of bepirovirsen, an antisense oligonucleotide, for the treatment of adults with chronic hepatitis B (CHB) NDA was supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in pts from 29 countries for the treatment of CHB Trials showed statistically significant &…

February 27, 2026

Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia

Shots: The US FDA has accepted sNDA & granted priority review to olezarsen for the treatment of severe hypertriglyceridemia (sHTG), with a PDUFA action date of Jun 30, 2026 sNDA was backed by the P-III (CORE: n=617 & CORE2: n=446) trials assessing olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in sHTG adults…

February 27, 2026

Galderma Announces OLYMPIA Extension Study Data on Nemluvio for Prurigo Nodularis

Shots: Galderma has reported OLYMPIA LTE study data assessing Nemluvio in 508 pts with prurigo nodularis up to 4yrs., from the P-II trial & the P-III (OLYMPIA 1 & 2) trials At Wk. 148, >70% of pts had clear or almost clear lesions per IGA score, >85% achieved ≥75% of healed lesions by prurigo activity…

February 27, 2026

Gan & Lee Pharmaceuticals Receives the CHMP Positive Opinion for Bysumlog and Dazparda (Biosimilar, Humalog and NovoRapid)

Shots: The CHMP has recommended marketing authorization for Bysumlog (insulin lispro) and Dazparda (insulin aspart), a biosimilar version of Humalog and NovoRapid, respectively, across all 30 EEA states Opinion was supported by P-I demonstrating biosimilarity and comparable safety of Bysumlog vs Humalog and Dazparda vs NovoLog/NovoRapid. Gan & Lee Pharmaceuticals signed a development, license, and commercialization agreement with Sandoz for three insulin biosimilars: glargine, lispro, and aspart. Upon approval, Sandoz…

February 27, 2026

Gedeon Richter Receives the CHMP Positive Opinion for Tuyory (Biosimilar, RoActemra)

Shots: The CHMP has recommended marketing authorization for Gedeon Richter’s Tuyory, a biosimilar version of RoActemra (Tocilizumab) Tuyory (tocilizumab) inhibits IL-6 signaling and is indicated for rheumatoid arthritis, juvenile idiopathic arthritis (including polyarthritis), giant cell arteritis, cytokine release syndrome, and COVID-19. It is available in both IV and SC forms, with dosing and presentations matching the reference product Tuyory was co-developed by Gedeon Richter and Mochida Pharmaceutical …

February 27, 2026

Bayer Reports P-III (PEACE-3) Trial Data on Xofigo Combination for Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Bone Metastases

Shots: Bayer has reported the P-III (PEACE-3) trial assessing Xofigo (radium-223 dichloride; 55kBq/kg, IV, QM for 6 cycles) + enzalutamide (160mg, PO, QD) vs enzalutamide in asymptomatic or mildly symptomatic pts (Brief Pain Inventory score <4) with mCRPC & ≥2 bone metastases Trial showed improved OS (2EP), with a 24% reduction in death risk &…

February 27, 2026

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for 1L HER2-Mutant NSCLC

Shots: The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the 1L treatment of pts with advanced NSCLC harboring HER2 (ERBB2) tyrosine kinase domain activating mutations Approval was based on the data from a treatment-naïve cohort (N=72) of the P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 76% (11%…

February 27, 2026

Boehringer Ingelheim Inks $500M+ Deal with Sitryx Therapeutics for Novel Oral Immune Disease Therapies

Shots: Sitryx Therapeutics has granted BI an exclusive license to a preclinical, small molecule program, offering a disease-modifying treatment approach across multiple autoimmune & inflammatory disease indications As per the deal, BI will receive an exclusive global license to the multiple assets & related IP to the small molecule inhibitor program, plus it will assume…

February 27, 2026

X4 Pharmaceuticals’ Xolremdi (Mavorixafor) Receives the CHMP Positive Opinion for WHIM Syndrome

Ipsen Reports the CHMP Positive Opinion for Ojemda (Tovorafenib) for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG)

GSK Reports the MHLW’s NDA Acceptance for Bepirovirsen to Treat Chronic Hepatitis B

Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia

Galderma Announces OLYMPIA Extension Study Data on Nemluvio for Prurigo Nodularis

Gan & Lee Pharmaceuticals Receives the CHMP Positive Opinion for Bysumlog and Dazparda (Biosimilar, Humalog and NovoRapid)

Gedeon Richter Receives the CHMP Positive Opinion for Tuyory (Biosimilar, RoActemra)

Bayer Reports P-III (PEACE-3) Trial Data on Xofigo Combination for Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Bone Metastases

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for 1L HER2-Mutant NSCLC

Boehringer Ingelheim Inks $500M+ Deal with Sitryx Therapeutics for Novel Oral Immune Disease Therapies

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