NEWS

Johnson & Johnson Receives the US FDA Approval for Rybrevant Faspro to Treat EGFR-Mutated NSCLC

Shots: FDA has approved J&J’s Rybrevant Faspro (amivantamab & hyaluronidase-lpuj, SC) for the treatment of pts with EGFRm NSCLC, covering all approved indications of Rybrevant Approval was backed by P-III (PALOMA-3) trial, evaluating SC vs IV RoA of Rybrevant, in combination with Lazcluze in advanced or metastatic EGFRm NSCLC pts (n=418) whose disease progressed on Tagrisso & Pt-based…

December 18, 2025

Takeda Reports Topline P-III (LATITUDE) Trials Findings on Zasocitinib in Plaque Psoriasis (PsO)

Shots: Takeda has reported data from 2 global P-III trials (NCT06088043 & NCT06108544) assessing zasocitinib (TAK-279) vs apremilast & PBO in 693 & 1108 adult pts, respectively, with mod. to sev. PsO Trial showed superiority to PBO on co-1EPs (sPGA 0/1 & PASI 75) at Wk. 16, with early PASI 75 responses from Wk. 4, sustained…

December 18, 2025

Merck Reports P-III (KEYNOTE-B15) Trial Finding on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The P-III (KEYNOTE-B15/EV-304) trial assessed 4 cycles of Keytruda (IV) + Padcev (IV), followed by surgery & then Keytruda (IV, 13 cycles) plus Padcev (IV, 5 cycles) vs neoadj. SoC + surgery in cisplatin-eligible MIBC pts (n=808) Trial showed that perioperative combination of Keytruda + Padcev significantly improved EFS, OS & pCR rates vs…

December 18, 2025

SleepRes’ Kricket PAP Device Receives the US FDA 510(k) Clearance for Obstructive Sleep Apnea

Shots: The US FDA has granted 510(k) clearance to the Kricket PAP device, powered by Kairos Positive Airway Pressure (KPAP), for the treatment of OSA pts (>66lbs) Kricket PAP device uses KPAP tech to dynamically adjust pressure with each breath, synchronizing with pts’ natural respiration to reduce unnecessary pressure, improve comfort & tolerance, & offering…

December 18, 2025

Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the CHMP Positive Opinion for Multiple Immune-Mediated Diseases

Shots: The CHMP has recommended Celltrion's Steqeyma autoinjector (45mg/0.5mL & 90mg/1mL), a biosimilar version of Stelara (ustekinumab), for the treatment of pts with plaque psoriasis, psoriatic arthritis (PsA) & Crohn’s disease (CD) SteQeyma (CT-P43) is a human anti-IL-12 & IL-23 monoclonal antibody that is also available in SC formulation (45mg/0.5 mL or 90mg/1 mL in…

December 18, 2025

Incyte’s Minjuvi (Tafasitamab) Combination Gains the EC Approval for R/R Follicular Lymphoma (FL)

Shots: The EC has approved Incyte's Minjuvi + rituximab & lenalidomide for the treatment of adults with r/r FL (Grade 1-3a) who received ≥1L of systemic therapy Approval was based on the P-III (inMIND) trial (N=654) assessing Minjuvi combination vs PBO + rituximab & lenalidomide in r/r FL or r/r nodal, splenic or extranodal MZL…

December 18, 2025

Kyverna Therapeutics Reports Topline P-II (KYSA-8) Trial Data of Miv-cel in Stiff Person Syndrome (SPS)

Shots: Kyverna has reported P-II (KYSA-8) trial data assessing a single dose of mivocabtagene autoleucel (miv-cel; KYV-101) in 26 SPS pts having an inadequate response with non-approved treatment options Trial met its 1EP with 46% median improvement in T25FW & 81% pts achieving a clinically meaningful ≥20% gain, plus significant benefits were seen across all…

December 17, 2025

May Health’s Anavi System Receives the European CE Mark for Women with PCOS-Related Infertility

Shots: May Health has received CE Mark for its Anavi System to treat PCOS-related infertility based on EU & US ULTRA studies in anovulatory or oligo-ovulatory women with PCOS who failed, declined, or were contraindicated to 1L therapy At 12mos. (26 evaluable pts/32), 77% (20/26) ovulated (13 spontaneously & 7 after restarting 1L therapy), with…

December 17, 2025

Vir Biotechnology Licenses Tobevibart & Elebsiran Combination to Norgine in EU, Australia and New Zealand

Shots: Vir Biotechnology has granted Norgine Pharma, an affiliate of Norgine exclusive commercial rights to the combination of tobevibart & elebsiran for the treatment of chronic hepatitis delta (CHD) in EU, Australia & New Zealand As per the deal, Vir will receive ~$64.5M (€ 55M) as initial reimbursement payment & ~ $581.3M (€ 495M) in…

December 17, 2025

Lupin Receive the CHMP Positive Opinion for Ranluspec (Biosimilar, Lucentis)

Shots: The CHMP has recommended marketing authorization for Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab) Opinion was supported by analytical similarity data and a global P-III trial (n=600 pts) in neovascular AMD across the US, EU, Russia, and India Under the agreement, Lupin’s biosimilar ranibizumab will be marketed by Sandoz across the EU (excluding Germany),…

December 17, 2025

NEWS

Johnson & Johnson Receives the US FDA Approval for Rybrevant Faspro to Treat EGFR-Mutated NSCLC

Takeda Reports Topline P-III (LATITUDE) Trials Findings on Zasocitinib in Plaque Psoriasis (PsO)

Merck Reports P-III (KEYNOTE-B15) Trial Finding on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

SleepRes’ Kricket PAP Device Receives the US FDA 510(k) Clearance for Obstructive Sleep Apnea

Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the CHMP Positive Opinion for Multiple Immune-Mediated Diseases

Incyte’s Minjuvi (Tafasitamab) Combination Gains the EC Approval for R/R Follicular Lymphoma (FL)

Kyverna Therapeutics Reports Topline P-II (KYSA-8) Trial Data of Miv-cel in Stiff Person Syndrome (SPS)

May Health’s Anavi System Receives the European CE Mark for Women with PCOS-Related Infertility

Vir Biotechnology Licenses Tobevibart & Elebsiran Combination to Norgine in EU, Australia and New Zealand

Lupin Receive the CHMP Positive Opinion for Ranluspec (Biosimilar, Lucentis)

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