GSK Reports the EC Approval of Exdensur (Depemokimab) for Asthma with Type 2 Inflammation and CRSwNP

Shots: EC approved Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) with type 2 inflammation (eosinophilic) & as add-on therapy for inadequately controlled CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively In SWIFT-1 (n=382) & SWIFT-2 (n=380), Exdensur reduced asthma exacerbations by 58% & 48% over 52wks. (1EP), with pooled data showing a 72%…

ByRidhi RastogiFebruary 17, 2026

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The EC Approves Amgen’s Uplizna (Inebilizumab) to Treat Generalized Myasthenia Gravis (gMG)

Shots: The EC has approved Uplizna (inebilizumab) as an add-on treatment of anti-AChR & anti-MuSK antibody positive adults with gMG Approval was based on P-III (MINT) trial in 238 adults with gMG (190 AChR+, 48 MuSK+), where pts received 2 Uplizna loading doses followed by 2 doses/year Pts on steroids began tapering at Wk. 4,…

ByRidhi RastogiFebruary 13, 2026

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Novocure Receives the US FDA Approval of Optune Pax with CT for Pancreatic Cancer

Shots: Approval was based on the P-III (PANOVA-3) trial assessing Optune Pax, a TTFields device used concomitantly with gemcitabine & nab-paclitaxel (n=285), vs CT alone (n=286) in 571 adults with locally advanced pancreatic cancer Trial improved mOS to 16.2 vs 14.2mos. in ITT, with 1yr. survival of 68.1% vs 60.2%. In mPP (198 received Optune…

ByRidhi RastogiFebruary 12, 2026

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Kelun-Biotech Reports NMPA Approval of Sacituzumab Tirumotecan for HR+/HER2- Breast Cancer

Shots: The Chinese NMPA has approved sacituzumab tirumotecan for the treatment of adults with unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine therapy & ≥1L of CT in an advanced setting Approval was based on the P-III (OptiTROP-Breast02) trial assessing sac-TMT vs CT for the…

ByRidhi RastogiFebruary 6, 2026

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GSK Reports the EC Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The EC has approved Nucala as an add-on maintenance treatment of adults with uncontrolled COPD characterised by raised blood eosinophils phenotype on a combination of an inhaled corticosteroid, a long-acting beta2-agonist (LABA), & a long-acting muscarinic antagonist Approval was based on the P-III (MATINEE) trial assessing Nucala (100mg, SC, Q4W; n=403) vs PBO (n=401)…

ByRidhi RastogiFebruary 6, 2026

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Hologic’s Aptima HPV Assay Receives the US FDA Approval for HPV Primary Screening

Shots: The US FDA has approved AptimaHPV Assay, an mRNA-based assay for clinician-collected HPV primary screening Approval follows completion of a real-world HPV screening study of 650,000+ women across US, showing the Aptima HPV Assay has clinically comparable sensitivity to an FDA-approved DNA-based HPV test & is effective for detecting CIN2+ & CIN3+ in primary…

ByRidhi RastogiFebruary 5, 2026

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Natera Seeks US FDA Approval for Signatera Cdx To Support MRD-Guided Treatment in Bladder Cancer

Shots: The US FDA has received a premarket approval (PMA) application of Signatera CDx for the detection of molecular residual disease (MRD) in pts with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with Tecentriq (atezolizumab) Submission was supported by the P-III (IMvigor011) trial, which met its 1EP & showed that Signatera-guided therapy improved…

ByRidhi RastogiFebruary 2, 2026

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NEXTBIOMEDICAL’s Nexsphere-F Receives Health Canada Approval For Musculoskeletal Pain Embolization

Shots: Health Canada has approved Nexsphere-F for the treatment of musculoskeletal pain embolization Nexsphere-F has launched the pivotal RESORB trial in the US post-IDE approval in 126 knee osteoarthritis pts comparing genicular artery embolization vs corticosteroid injections, with enrollment expected to complete in H1’26 Nexsphere-F uses resorbable microsphere tech to temporarily block abnormal blood flow…

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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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

GSK Reports the EC Approval of Exdensur (Depemokimab) for Asthma with Type 2 Inflammation and CRSwNP

The EC Approves Amgen’s Uplizna (Inebilizumab) to Treat Generalized Myasthenia Gravis (gMG)

Novocure Receives the US FDA Approval of Optune Pax with CT for Pancreatic Cancer

Kelun-Biotech Reports NMPA Approval of Sacituzumab Tirumotecan for HR+/HER2- Breast Cancer

GSK Reports the EC Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Hologic’s Aptima HPV Assay Receives the US FDA Approval for HPV Primary Screening

Natera Seeks US FDA Approval for Signatera Cdx To Support MRD-Guided Treatment in Bladder Cancer

NEXTBIOMEDICAL’s Nexsphere-F Receives Health Canada Approval For Musculoskeletal Pain Embolization

Almirall Reports the NMPA Approval of Seysara to Treat Acne

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

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