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Zimmer Biomet Receives FDA 510(k) Clearance for ROSA Knee with OptimiZe #zimmerbiomet #rosaknee #optimize #kneereplacement #surgicalplanning #510kclearance #medtech #usfda #zbedgeanalytics #personakneeplatform pharmashots.com/29458/zimmer-b…

Incyte’s Minjuvi Combination Gains the CHMP’s Positive Opinion for R/R Follicular Lymphoma (FL) #incyte #monjuvi #tafasitamab #rituximab #chmp #piii #inmind #ash2024 #regulatory #icml2025 #icpb04 #incmor0208 #mor00208 #xenp5574 #xmab5574 #minjuvi pharmashots.com/29461/incytes-…

PharmaShots' latest interview with Pablo Panella (SVP, AstraZeneca ) dives into the EU’s recommendation of Saphnelo SC , a once-weekly, self-administered pre-filled pen reshaping SLE care. #astrazeneca #viewpoint #sle #pharmashots pharmashots.com/29462/navigati…

Johnson & Johnson Strengthens its Oncology Pipeline with $3.05B Acquisition of Halda Therapeutics #jnj #haldatherapeutics #oncology #prostatecancer #hld0915 #riptacplatform #solidtumors #pi #pii #acquisition #ma pharmashots.com/29469/jj-accel…

The US FDA accepts Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) sNDA, aiming to broaden Zoryve use to children aged 2-5 with plaque psoriasis #arcutis #usfda #snda #zoryve #roflumilast #plaquepsoriasis #pdufa #muse #pde4inhibitor #arq151 #arq154 pharmashots.com/29473/arcutis-…

The EC Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair) #ec #approval #celltrion #omlyclo #biosimilar #xolair #allergicasthma #chronicspontaneousurticaria #crswnp #monoclonalantibody pharmashots.com/29475/the-ec-a…

Merus Partners with Halozyme to Develop Subcutaneous Petosemtamab #merus #halozyme #enhanze #collaboration #drugdelivery #licensingdeal #petosemtamab #rhuph20 #subcutaneous #pharma pharmashots.com/29479/merus-pa…

Genentech (Roche) Reports Interim P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer #genentech #roche #piii #liderabreastcancer #giredestrant #everabreastcancer #clinicaltrial #rg6171 #gdc9545 #ro7197597 pharmashots.com/29485/genentec…

Genmab and AbbVie Report the US FDA Approval of Epkinly to Treat R/R Follicular Lymphoma #genmab #abbvie #epkinly #follicularlymphoma #usfda #epcoritamab #piii #epcorefl1 #ash2025 #regulatory #gen3013 #gmab3013 pharmashots.com/29490/genmab-a…

Arrowhead Pharmaceuticals Receives the US FDA’s Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS) #arrowhead #usfda #approval #redemplo #plozasiran #fcs #palisade #piii #thenejm #circulation #esc2024 #aha2024 #regulatory pharmashots.com/29493/arrowhea…

GSK Collaborates with LTZ Therapeutics to Advance Myeloid Cell Engager Therapies in Oncology #gsk #ltztherapeutics #myeloidcellengager #oncology #hematologiccancers #solidtumors #immuneengagerplatform #pharma #collaboration #researcher pharmashots.com/29496/gsk-coll…

Merck Reports P-II (CADENCE) Trial Data on Winrevair for Combined Post and Precapillary Pulmonary Hypertension (CpcPH) due to HFpEF #merck #pii #cadence #winrevair #sotatercept #cpch #hfpef #toplinedata #clinicaltrial #ace011 #rap011 #mk7962 pharmashots.com/29499/merck-re…

Insmed Reports the EC’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB) #insmed #brinsupri #brensocatib #azd7986 #ins1007 #ncfb #aspen #willow #piii #pii #pulmonaryexacerbations #ec #approval #regulatory #pmda #mhra pharmashots.com/29501/insmed-r…

Henlius and Organon’s Poherdy (Biosimilar, Perjeta) receives FDA approval, expanding access for patients with certain HER2-positive breast cancers in the US #henlius #organon #usfda #approval #poherdy #biosimilar #perjeta #pertuzumab #licensingdeal pharmashots.com/29503/henlius-…

Bayer Reports the EC Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms #bayer #lynkuet #elinzanetant #vasomotorsymptoms #hotflashes #oasis1 #oasis2 #oasis3 #piii #ec #approval #nt814 #bay3427080 #gsk1144814 #oasis4 #regulatory pharmashots.com/29506/bayer-re…

Merck’s Keytruda SC Receives the EC Approval for Subcutaneous Use Across 33 Solid Tumor Indications for Keytruda #merck #keytrudasc #keytrudaqlex #pembrolizumab #keytruda #3475ad77 #piii #nsclc #ec #berahyaluronidasealfa #approval #regulatory pharmashots.com/29508/mercks-k…

Innovent Biologics Reports P-III (GLORY-2) Trial Data on Mazdutide for Obesity #innovent #mazdutide #ibi362 #glory2 #glory1 #dreams1 #dreams2 #dreams3 #obesity #type2diabetes #weightmanagement #weightloss #glp1 #gcgr #nmpa #nda pharmashots.com/29510/innovent…

Merck Reveals Topline P-III (MK-8591A-053) Trial Data on Doravirine/Islatravir to Treat HIV-1 Infection #merck #toplinedata #piii #mk8591a053 #doravirine #islatravir #hiv1infection #usfda #nda #pdufa #clinicaltrial pharmashots.com/29512/merck-re…

Alvotech and Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the EC Approval to Treat Several Chronic Inflammatory Diseases #alvotech #gobivaz #ec #biosimilar #inflammatorydiseases #simponi #golimumab #advanzpharma #Avtur pharmashots.com/29514/alvotech…

AstraZeneca reports the US FDA approval of Koselugo (selumetinib) for neurofibromatosis type 1 #astrazeneca #koselugo #neurofibromatosis #type1 #plexiformneurofibromas pharmashots.com/29517/astrazen…