Johnson & Johnson Gains CHMP Positive Opinion for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The CHMP has recommended label expansion of Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone + androgen deprivation therapy (ADT) to treat adults with mHSPC & BRCA1/2 mutations Opinion was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic…

ByRidhi RastogiFebruary 2, 2026

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Sanofi Receives the CHMP Positive Opinion for Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

Shots: The CHMP has recommended Rezurock (200mg) for conditional approval in chronic GVHD pts (≥12yrs., ≥40kg), with EC’s decision expected in the coming wks. Opinion was supported by extensive clinical data, incl. the P-II (ROCKstar) trial, which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic…

ByRidhi RastogiFebruary 2, 2026

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UCB Reports the CHMP Positive Opinion of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Shots: The CHMP has recommended Kygevvi (PO) under exceptional circumstances for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age, supported through EMA's PRIME scheme. EC decision is expected by Q2’26 Supportive evidence came from pooled data from 2 studies of Kygevvi in 39 pts with genetically confirmed TK2d & symptom…

ByRidhi RastogiFebruary 2, 2026

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ALK’s EURneffy 1mg Secures the CHMP Positive Opinion to Treat Allergic Reactions in Children

Shots: The CHMP has recommended EURneffy 1mg (adrenaline nasal spray) to treat allergic reactions as well as idiopathic or exercise-induced anaphylaxis in children (≥4yrs. & 15-30kg) If granted, the approval would be valid in all 30 EEA states & will support an extension to the existing EURneffy 2 mg’s approval from Aug 2024 for emergency…

ByRidhi RastogiJanuary 30, 2026

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Summit Therapeutics Reports the US FDA’s BLA Acceptance for Ivonescimab to Treat EGFRm Non-Squamous NSCLC

Shots: The US FDA has accepted BLA of ivonescimab + CT for the treatment of EGFR-mutated locally advanced or metastatic non-squamous NSCLC post-TKI therapy (PDUFA: Nov 14, 2026) BLA was supported by P-III (HARMONi) trial assessing ivonescimab + Pt-doublet CT vs PBO + Pt-doublet CT in pts with EGFR-mutated, locally advanced or metastatic NSCLC who…

ByRidhi RastogiJanuary 30, 2026

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Almirall Reports the NMPA Approval of Seysara to Treat Acne

Shots: The Chinese NMPA has approved Seysara (sarecycline hydrochloride) for the treatment of inflammatory lesions of non-nodular mod. to sev. acne vulgaris in patients (≥9yrs.) Seysara’s efficacy was validated across multiple trials, with real-world evidence from the PROSES study & clinical studies in diverse patient populations in the US & China confirming its relevance across…

ByRidhi RastogiJanuary 29, 2026

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Gedeon Richter Receives the CHMP Positive Opinion for Fylrevy for Hormone Replacement Therapy (HRT)

Shots: The CHMP has recommended Fylrevy (estetrol/Donesta) as HRT for oestrogen deficiency symptoms in postmenopausal women, both non-hysterectomised (14.2 mg and 18.9 mg) and hysterectomized (18.9 mg); the decision will be anticipated across EEA markets Fylrevy is an oral estetrol-based oestrogen therapy designed to treat a broad range of oestrogen deficiency symptoms, including VMS, in postmenopausal women Preclinical and clinical data…

ByDipanshu DixitJanuary 29, 2026

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Tenpoint Therapeutics Reports the US FDA Approval of Yuvezzi to Treat Presbyopia

Shots: The US FDA has approved Yuvezzi (carbachol & brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol PF, for the treatment of presbyopia in adults; commercially available by Q2’26 Approval was backed by 2 P-III (BRIO I & BRIO II) trials (n>800), with BRIO I showing superior benefit vs individual actives & BRIO II…

ByRidhi RastogiJanuary 29, 2026

NEWS

Elevar Therapeutics Seeks the US FDA Approval for Lirafugratinib to Treat Cholangiocarcinoma

Shots: The US FDA has received an NDA of lirafugratinib for the 2L treatment of cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement NDA was backed by the P-I/II (ReFocus) trial, which showed 46.5% ORR, 12mos. PFS rate of 49.2% (mPFS: 11.3mos.), 12mos. OS of 74.6% (mOS: 22.8mos.), DCR of 96.5%, & mDoR of 11.8mos.,…

ByRidhi RastogiJanuary 29, 2026

NEWS

Johnson & Johnson Receives the US FDA’s Approval for Darzalex FASPRO Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The US FDA has approved Darzalex FASPRO (daratumumab and hyaluronidase-fihj) + bortezomib, lenalidomide & dexamethasone (D-VRd) for adults with NDMM who are ineligible for autologous stem cell transplant. Approval was based on the P-III (CEPHEUS) trial, assessing D-VRd vs VRd in 395 ASCT-ineligible or deferred patients across 13 countries in the EU, North America,…

ByDipanshu DixitJanuary 28, 2026

Johnson & Johnson Gains CHMP Positive Opinion for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Sanofi Receives the CHMP Positive Opinion for Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

UCB Reports the CHMP Positive Opinion of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

ALK’s EURneffy 1mg Secures the CHMP Positive Opinion to Treat Allergic Reactions in Children

Summit Therapeutics Reports the US FDA’s BLA Acceptance for Ivonescimab to Treat EGFRm Non-Squamous NSCLC

Almirall Reports the NMPA Approval of Seysara to Treat Acne

Gedeon Richter Receives the CHMP Positive Opinion for Fylrevy for Hormone Replacement Therapy (HRT)

Tenpoint Therapeutics Reports the US FDA Approval of Yuvezzi to Treat Presbyopia

Elevar Therapeutics Seeks the US FDA Approval for Lirafugratinib to Treat Cholangiocarcinoma

Johnson & Johnson Receives the US FDA’s Approval for Darzalex FASPRO Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

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