PharmaShots | Your partner in biopharma & healthcare insights. Connecting decision-makers & brands through sharp news, impactful insights and leader interviews
Noida, Uttar Pradesh, India
Joined July 2018
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The US FDA Approves @novonordisk's Awiqli (Insulin Icodec) as the First Once-Weekly Basal Insulin for Pediatric Type 2 Diabetes
#novonordisk #awiqli #insulinicodecabae #fdaapproval #usfda #type2diabetes #pediatricdiabetes #diabetesmanagement #basalinsulin #weeklyinsulin
pharmashots.com/36758/fda-ap…
China’s NMPA Approves @bio_thera_sol's BAT2306 (Biosimilar, Cosentyx) as the First Secukinumab Biosimilar in China
#biotherasolutions #bat2306 #secukinumab #biosimilar #biosimilarapproval #nmpaapproval #chinaapproval #regulatoryapproval #psoriasis #ankylosingspondylitis #psoriaticarthritis
pharmashots.com/36752/nmpa-a…
The US FDA Approves @abbvie's Skyrizi (Risankizumab) Subcutaneous Induction Regimen for Crohn’s Disease
#abbvie #skyrizi #risankizumab #usfda #fdaapproval #crohnsdisease #inflammatoryboweldisease #ibd #gastroenterology #immunology
pharmashots.com/36706/fda-ap…
The US FDA Accepts @unicycive's NDA Resubmission for Oxylanthanum Carbonate to Treat Hyperphosphatemia in CKD Patients on Dialysis
#unicycivetherapeutics #oxylanthanumcarbonate #olc #usfda #nda #ndaresubmission #fdaacceptance #completeresponseletter #crl #classiiresubmission
pharmashots.com/36614/unicyc…
The US FDA Accepts @argenxglobal's sBLA for Vyvgart and Vyvgart Hytrulo with Priority Review for Pediatric Generalized Myasthenia Gravis (gMG)
#argenx #vyvgart #vyvgarthytrulo #efgartigimodalfa #usfda #priorityreview #sbla #pdufa #february2027 #generalizedmyastheniagravis #gmg #pediatricgmg
pharmashots.com/36607/argenx…
Elucid Receives the US FDA’s 510(k) Clearance for FFR-IQ Software for Noninvasive FFR-CT Assessment
#elucid #ffriq #usfda #510kclearance #fda510k #artificialintelligence #ai #aipowered #biointegrated #ffrct #fractionalflowreserve #coronaryarterydisease
pharmashots.com/36591/elucid…
Rapport Therapeutics Reports Topline P-II Trial Results on RAP-219 in Bipolar Mania
#rapporttherapeutics #rap219 #phase2 #phase3 #clinicaltrial #clinicalresearch #bipolardisorder #bipolarmania #acutemania #ymrs #youngmaniaratingscale
pharmashots.com/36547/rappor…
Cosette Pharmaceuticals Receives FDA Approval for Evoxac Oral Solution to Treat Dry Mouth in Sjögren’s Disease Patients
#cosettepharmaceuticals #evoxac #cevimelinehcl #usfda #fdaapproval #oralsolution #sjojgrensdisease #sjogrenssyndrome #drymouth
pharmashots.com/36516/cosett…
The US FDA Approves @GSK's Hibsago (Bepirovirsen) for Chronic Hepatitis B (CHB)
#gsk #hibsago #bepirovirsen #usfda #fdaapproval #chronichepatitisb #hepatitisb #hbv #antisenseoligonucleotide #aso
pharmashots.com/36513/the-us…
METiS Therapeutics partners with Eli Lilly and Company to advance AI-powered, tissue-specific lipid nanoparticle (LNP) delivery technologies in a deal worth up to $1.1 billion in milestones, plus royalties, aiming to improve therapeutic targeting and delivery across disease areas.
#lnp #partnership #pharmashots
pharmashots.com/36507/metis-…
EyePoint reported that Duravyu missed the primary endpoint in its Phase III LUCIA trial for wet AMD but achieved key secondary endpoints, including a 38% reduction in treatment burden. The company will analyze the data to determine next steps.
#eyepoint #duravyu #lucia #pharmashots
pharmashots.com/36495/eyepoi…
Zentalis Pharmaceuticals reports first overall survival data from the Phase II DENALI study of azenosertib in platinum-resistant ovarian cancer. Median OS reached 15.8 months in Cyclin E1-positive patients versus 7.5 months in Cyclin E1-negative patients, supporting further evaluation of this investigational WEE1 inhibitor.
#Zentalis #ESMO2026 #OvarianCancer #Oncology #ClinicalTrials #Azenosertib #PharmaShots
pharmashots.com/36436/zental…
Zentalis Pharmaceuticals reports first overall survival data from the Phase II DENALI study of azenosertib in platinum-resistant ovarian cancer. Median OS reached 15.8 months in Cyclin E1-positive patients versus 7.5 months in Cyclin E1-negative patients, supporting further evaluation of this investigational WEE1 inhibitor.
#Zentalis #ESMO2026 #OvarianCancer #Oncology #ClinicalTrials #Azenosertib #PharmaShots
pharmashots.com/36436/zental…
Mabwell reports Phase II data for 9MW2821 (bulumtatug fuvedotin) in Topo I ADC-pretreated triple-negative breast cancer at ESMO 2026. Among 60 patients, the Nectin-4-targeting ADC achieved a 30% ORR and 80% DCR, with no new safety signals observed.
#Mabwell #ESMO2026 #TNBC #ADC #Oncology #ClinicalTrials #PharmaShots
pharmashots.com/36439/mabwel…
Mabwell reports Phase II data for 9MW2821 (bulumtatug fuvedotin) in Topo I ADC-pretreated triple-negative breast cancer at ESMO 2026. Among 60 patients, the Nectin-4-targeting ADC achieved a 30% ORR and 80% DCR, with no new safety signals observed.
#Mabwell #ESMO2026 #TNBC #ADC #Oncology #ClinicalTrials #PharmaShots
pharmashots.com/36439/mabwel…
ImmunityBio, Inc. reported long-term QUILT-3.032 data showing a 71% complete response rate with Anktiva plus BCG in BCG-unresponsive NMIBC with CIS, with a median response duration of 26.6 months and 84% cystectomy-free survival at 36 months among responders, supporting durable disease control and bladder preservation.
#ImmunityBio #Anktiva #BladderCancer #NMIBC #CancerResearch #Immunotherapy #Oncology #ClinicalTrials #ClinicalResearch #Urology #BCG #CancerTreatment #Biopharmaceuticals #FDAApproval #PharmaShots
pharmashots.com/36442/immuni…
Masimo received US FDA 510(k) clearance for its PPG-based AFib detection capability on Radius VSM, expanding its smartSET platform alongside its previously cleared AI-enabled OIRD detection to support earlier identification of potential cardiac arrhythmias and opioid-related respiratory risks.
#Masimo #FDA510k #AFibDetection #PulseOximetry #MedicalDevices #DigitalHealth #HealthcareInnovation #ArtificialIntelligence #PatientMonitoring #CardiacCare #AtrialFibrillation #ClinicalInnovation #Danaher #HealthcareTechnology #PharmaShots
pharmashots.com/36445/masimo…
Masimo received US FDA 510(k) clearance for its PPG-based AFib detection capability on Radius VSM, expanding its smartSET platform alongside its previously cleared AI-enabled OIRD detection to support earlier identification of potential cardiac arrhythmias and opioid-related respiratory risks.
#Masimo #FDA510k #AFibDetection #PulseOximetry #MedicalDevices #DigitalHealth #HealthcareInnovation #ArtificialIntelligence #PatientMonitoring #CardiacCare #AtrialFibrillation #ClinicalInnovation #Danaher #HealthcareTechnology #PharmaShots
pharmashots.com/36445/masimo…
Nanexa and @novonordisk Ink ~ €1.165B Deal for Long-Acting Injectables
#nanexa #novonordisk #licensingdeal #pharmashell #drugdeliveryplatform #drugdelivery #peptides
pharmashots.com/35948/nanexa…
