Pharma News

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#FDAApprovals

🔊 J&J’s Tremfya (guselkumab) Gains FDA Approval for Moderately to Severely Active Crohn’s Disease in Adults
🔊 Soleno’s VYKAT XR Wins FDA Approval for Hyperphagia in Prader-Willi Syndrome
🔊 GSK's Blujepa (gepotidacin) Receives FDA Approval for Uncomplicated Urinary Tract Infections in Women and Children
🔊 Exelixis' Cabometyx Gains FDA Approval for Neuroendocrine Tumors in Patients Aged 12 and Older
🔊 Alnylam’s Amvuttra (Vutrisiran) Wins FDA Approval for ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)
🔊 Fresenius Kabi Biopharma Receives FDA Approval for Conexxence and Bomyntra Biosimilars in Osteoporosis, Bone Metastases, and Related Conditions

#Regulatory(Japan) 

🔊 BridgeBio Pharma’s Beyonttra Wins Japan Approval for ATTR-CM Treatment
🔊 Japan Approves Genmab’s Tivdak for Advanced Cervical Cancer Following Phase 3 Success
🔊 Rhythm Pharmaceuticals Reacquires IMCIVREE (setmelanotide) Rights in China for Obesity Treatment

#Deal

🔊 Merck Bets $200M on Jiangsu Hengrui's Lp(a)-Blocking Heart Pill in $1.97B Deal
🔊 Kelso Pharma Secures £140M in Funding for Expansion

#FDAApprovals

🔊 Madrigal Pharmaceuticals’ Resmetirom Secures Historic FDA Approval for MASH Treatment
🔊 FDA Grants Standard Approval to Merck’s Pembrolizumab, Trastuzumab, Chemotherapy for HER2-Positive Gastric Cancer
🔊 FDA Grants Approval for Scienture's Arbli to Reduce Stroke Risk in Hypertension
🔊 Alnylam’s Amvuttra Receives FDA Approval for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
🔊 ANI Pharmaceuticals Gains FDA Approval for ILUVIEN Label Expansion for NIU-PS & DME
 

#Deal

🔊 Taiho Pharmaceutical Acquires Araris Biotech for $1.1B to Advance ADC Technology in Oncology
🔊 AstraZeneca Acquires EsoBiotech for $1B to Advance In Vivo Cell Therapy for Cancer and Autoimmune Diseases
🔊 Paratek Acquires Optinose for Up to $330M, Expanding Portfolio with Xhance for CRS
🔊 Liquidia Secures Up to $100M to Advance YUTREPIA for PAH and PH-ILD

#Trial

🔊 Zealand Pharma Completes Enrollment in Phase 2b ZUPREME-1 Trial of Petrelentide for Obesity

#FDAApprovals

🔊 Alexion and AstraZeneca's Eculizumab Gains FDA Approval for Pediatric Generalized Myasthenia Gravis
🔊 Biocon Pharma's Lenalidomide and Dasatinib Receive FDA Approval for Multiple Hematologic Malignancies
🔊 scPharmaceuticals Gains FDA Approval to Extend Furoscix Indication for CKD Edema Management
🔊 Zydus Lifesciences Receives FDA Approval for Methenamine Hippurate Tablets for Urinary Tract Infections
🔊 Celltrion Receives FDA Approval for Stoboclo and Osenvelt Biosimilars in Cancer Care
🔊 Celltrion’s Omlyclo Wins FDA Approval as First Interchangeable Biosimilar to Xolair

#Regulatory (EMA)

🔊 MaaT Pharma’s MaaT013 Receives Positive EMA Pediatric Committee Opinion for aGvHD Treatment

#Deal

🔊 Zealand Pharma, Roche Ink $5.3B Deal to Develop Petrelintide for Weight Management
🔊 Jazz Pharma Acquires Chimerix for $935M, Gaining First-in-Class Brain Cancer Drug Dordaviprone
🔊 Salipro Biotech and Boehringer Ingelheim Partner to Advance GPCR and Membrane Protein Drug Discovery

#Other

🔊 Biodexa Selects Precision for Medicine as CRO for European Phase 3 Study of eRapa in FAP
🔊Roche Writes Off $2.4B in Spark Gene Therapy Overhaul

#FDAApprovals

🔊FDA Approves BeiGene’s Tevimbra Plus Chemo for Advanced Oesophageal Cancer 

🔊Tevimbra Receives FDA Approval as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma 

🔊Neurotech Pharmaceuticals' Encelto Receives FDA Approval for Macular Telangiectasia Type 2

🔊Genentech's TNKase Receives FDA Approval for Acute Ischemic Stroke Treatment

🔊ARS Pharmaceuticals' Neffy Gains FDA Approval for Type 1 Allergic Reactions in Pediatric Patients

🔊Celltrion’s Stoboclo and Osenvelt Biosimilars Gain FDA Approval for Osteoporosis and Skeletal Events in Cancer 

🔊FDA Approves First Generic of Rivaroxaban by Taro Pharmaceuticals for CAD and PAD

#Regulatory (EMA)

🔊Johnson & Johnson’s Darzalex Gains Positive CHMP Opinion for Newly Diagnosed Multiple Myeloma

🔊CHMP Recommends Regeneron’s Lynozyfic and Novartis’ Fabhalta for Multiple Myeloma and C3G

#Deal

🔊AbbVie Signs $2.3bn Deal to License Gubra's Obesity Drug GUB014295

🔊Jazz Pharmaceuticals Buys Chimerix for $935M, Gaining Dordaviprone for Rare Brain Cancer

#FDAApprovals

🔊 Mirum’s Ctexli Wins FDA Approval for Rare Metabolic Disease Cerebrotendinous Xanthomatosis
#Deal

🔊 Eli Lilly's $10M Deal for Organovo’s FXR314 Targets Inflammatory Bowel Disease

🔊 Ignota Labs Secures $6.9M to Advance AI-Powered Drug Turnaround and Clinical Trials

#TrialUpdate

🔊 Emalex Biosciences Advances Ecopipam for Tourette Syndrome After Phase III Trial Success
🔊 FDA Greenlights Cambium Bio’s Phase 3 Trial Protocol for Elate Ocular in Dry Eye Disease
🔊 Allarity Therapeutics Begins Phase 2 Enrollment for Stenoparib in Advanced Ovarian Cancer

#Other

🔊Pfizer Discontinues Hemophilia Gene Therapy Beqvez, Exiting the Gene Therapy Space

🔊 FDA Grants Full Approval to Deciphera’s ROMVIMZA for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)
🔊 GSK’s Penmenvy Wins FDA Approval for 5-in-1 Vaccine Against Meningococcal Disease
🔊 FDA Approves Bavarian Nordic's Vimkunya Vaccine for Chikungunya Virus
🔊 Cipla Gains FDA Approval for Nilotinib Capsules to Treat Chronic Myeloid Leukemia
🔊 FDA Approves Vertex’s Journavx (Suzetrigine) for Acute Pain, Paving the Way for Non-Opioid Pain Relief
🔊 Ono’s Romvimza Wins FDA Approval for Tenosynovial Giant Cell Tumor, Sets Up Rivalry with Daiichi Sankyo’s Turalio
🔊 Sanofis Merilog Gains FDA Approval as the First Biosimilar to Novo Nordisk's NovoLog (Insulin Aspart)
🔊 Amneal Gains FDA Approval for Generic Lenalidomide
🔊 FDA Approves Ospomyv and Xbryk Biosimilars for Postmenopausal Osteoporosis and Cancer-Related Bone Loss
🔊 InnoCare Pharma's Combination Therapy Gets NMPA Approval for CLL/SLL in China
🔊 AstraZeneca Expands Chinese Presence with $160 Million FibroGen Acquisition
🔊 AlzeCure Pharma Secures €2.5M Grant for Phase IIa Trial of NeuroRestore ACD856 in Alzheimer’s Disease
🔊 FDA Accepts Gilead’s Lenacapavir New Drug Application for HIV Prevention
🔊 Innate Pharma’s Lacutamab Wins FDA Breakthrough Therapy for Sézary Syndrome 

🔊 Pfizer’s Adcetris Combo Wins FDA Approval for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
🔊 AbbVie Secures FDA Approval for Emblaveo Amid Rising Antibiotic Resistance
🔊 Genentech's Evrysdi (Risdiplam) Tablet Receives FDA Approval for Spinal Muscular Atrophy
🔊 Bain Capital Acquires Mitsubishi Tanabe for $3.4B to Boost CNS, Immunology, and Cancer Drug Pipeline
🔊 OliX Partners with Eli Lilly in $630M Deal for Obesity and Liver Disease Drug OLX75016
🔊 FDA Approves Ocugen’s Investigational Nasal COVID-19 Vaccine for Phase 1 Trial

🔊 Highmark Health Expands Access to Stanza, FDA-Cleared Digital Therapy for Fibromyalgia
🔊DarioHealth Secures New Blue Cross Blue Shield Agreement, Expanding Health Plan Network and AI-Driven Digital Solutions
🔊Daewoong Expands Digital Healthcare Horizons with thynC and AI Wearable Tech
🔊AI Sleep Tech Gains South Korea’s Innovative Medical Device Designation
🔊Korea’s Neurive Pioneers Digital Therapy for Tinnitus with SoriCLEAR
🔊Evaluating Priorities, Quality, and Inclusivity in Digital Therapeutics Trials in China

🔊AstraZeneca’s Calquence Wins FDA Approval as First-Line Treatment for Mantle Cell Lymphoma
🔊Vertex Pharmaceuticals' Journavx Wins FDA Approval for Acute Pain Treatment

🔊Novo Nordisk’s Ozempic Wins FDA Nod to Lower Kidney Disease Risk in Diabetes
🔊Celltrion's Avtozma Biosimilar Wins US FDA Approval for Autoimmune Diseases
🔊FDA Grants Eisai and Biogen’s Alzheimer’s Drug Leqembi Monthly Dosing Approval

🔊AstraZeneca's Calquence Gets Full FDA Approval for Mantle Cell Lymphoma
🔊AstraZeneca and Daiichi Sankyo’s Datroway Receives US FDA Approval for Advanced Breast Cancer
🔊J&J’s Spravato Approved by FDA as Monotherapy for Treatment-Resistant Major Depressive Disorder
🔊Amneal Gains FDA Approval for Dementia and Oncology Drugs
🔊DyDo Pharma, Sub-Licensee of Catalyst Pharmaceuticals, Launches Firdapse in Japan for LEMS Treatment

🔊Autolus Therapeutics Secures FDA Approval for Aucatzyl Cell Therapy in Relapsed B-Cell Leukemia

🔊FDA Approves Amgen’s Sotorasib and Panitumumab for KRAS G12C-Mutated Colorectal Cancer

🔊Eli Lilly’s Omvoh (Mirikizumab) Receives FDA Approval for Crohn’s Disease Treatment

🔊Eli Lilly Invests $2.5B in Scorpion’s PI3Ka Inhibitor for Breast and Gynecological Cancers

🔊GSK Acquires IDRx in $1.15B Deal to Target Rare Gastrointestinal Cancers

🔊Cycle Pharma Acquires Banner Life Sciences and Bafiertam for Multiple sclerosis Treatment

🔊Pfizer’s Sasanlimab Surpasses BCG Alone in Phase III Bladder Cancer Trial

🔊FDA Clears Tyra Biosciences’ TYRA-300 for Phase 2 Trial in Bladder Cancer

🔊ImmunoForge Receives FDA IND Approval for Phase 2 Trial of Pemziviptadil for DMD Cardiomyopathy Treatment

🔊FDA Approves ANI Pharmaceuticals Generic Prucalopride, the Alternative to Motegrity
🔊Dimerix and Fuso Ink A$100 Million Deal for Focal Segmental Glomerulosclerosis (FSGS) Drug Development in Japan
🔊Meiji Seika Pharma Enters $20M Deal with MPM BioImpact to Develop Next-Gen Antivirals and Biologic Therapies
🔊Kaken Pharma Signs $1.2B License Agreement with J&J for STAT6 Inhibitor KP-723 in Type 2 Inflammatory Diseases
🔊Eli Lilly and Alchemab to Co-Develop Amyotrophic Lateral Sclerosis (ALS) Antibodies Leveraging Novel Platform
🔊Newron Partners with Myung In Pharm to Develop Evenamide for Schizophrenia in South Korea
🔊UCB Partners with Ailux Biologics to Accelerate Immune and CNS Disease Therapy Development
🔊Bayer's Elinzanetant Shows Key Trial Success in Breast Cancer Patients
🔊FDA Rejects Lexicon's Sotagliflozin (Zynquista) for Type 1 Diabetes and CKD
🔊Athira Pharma Settles Research Misconduct Case for $4M Over Alzheimer’s Grants

🔊 BMS's Opdivo Qvantig FDA-Approved for Subcutaneous Use in NSCLC and Solid Tumors
🔊BeOne Medicines (formerly BeiGene) Receives FDA Approval for TEVIMBRA in Gastric Cancer
🔊Array BioPharma's Braftovi Receives FDA Accelerated Approval for Metastatic Colorectal Cancer
🔊MHRA Approves Merck's Sotatercept (Winrevair) for Pulmonary Arterial Hypertension
🔊Roche Enters $1B Agreement with Innovent for Antibody-Drug Conjugate in Small Cell Lung Cancer
🔊Galera Completes $3M Acquisition of Nova Pharmaceuticals to Expand into Advanced Breast Cancer R&D
🔊Egypt Signs $120M Deal to Build Pharmaceutical Hub in Suez Canal Economic Zone
🔊HUTCHMED Divests 45% Stake in Shanghai Hutchison Pharmaceuticals for $608M
🔊Chimerix Seeks FDA Accelerated Approval for Dordaviprone in Recurrent H3K27M+ Diffuse Glioma Treatment
🔊NRx Pharmaceuticals Submits NDA for NRX-100 (IV Ketamine) for Treatment of Suicidal Depression
🔊Capricor Submits BLA for Deramiocel in Duchenne Muscular Dystrophy Cardiomyopathy
🔊Silo Pharma’s SPC-15 Advances for PTSD Treatment, Prepares for FDA IND Filing in 2025
🔊Cocrystal Pharma Extends Phase 2a Trial for Influenza Drug CC-42344; Stock Drops 35%
🔊MicuRx's MRX-5 Wins FDA Orphan Drug Designation for Non-tuberculous Mycobacteria Infections

🔊FDA Approves Hikma's First Generic GLP-1 Injection for Type 2 Diabetes
🔊Eli Lilly’s Zepbound Approved by FDA for Obesity-Linked Obstructive Sleep Apnea
🔊Rhythm Pharma's Setmelanotide Gains FDA Approval for Obesity in Children 2+ with Genetic Syndromes
🔊Pfizer's Braftovi Receives FDA Approval for Metastatic Colorectal Cancer with BRAF V600E Mutation
🔊Vertex Pharmaceuticals Gains FDA Approval for Alyftrek, a Triple Combo Therapy for Cystic Fibrosis
🔊Sumitomo Pharma Gets FDA Approval for Gemtesa in Men with OAB and BPH
🔊FDA Approves Novo Nordisk’s Alhemo as First Once-Daily Treatment for Hemophilia A and B with Inhibitors
🔊Astellas and Sangamo Forge $20M Partnership for Neurotropic AAV Capsid

 🔊 Merus's Bizengri Secures FDA Approval for Advanced Pancreatic Cancer and NSCLC
🔊FDA Grants Final Approval to Breckenridge's Methadone Injection for Pain and Opioid Treatment
🔊Ionis Pharmaceuticals Secures FDA Approval for Tryngolza to Treat Familial Chylomicronemia Syndrome
🔊Neurocrine's Crenessity™FDA-Approved for Classic Congenital Adrenal Hyperplasia
🔊FDA Approves Humacyte’s Symvess for Extremity Vascular Trauma Treatment
🔊FDA Approves Checkpoint's Unloxcyt, the First Anti-PD-L1 Drug for Metastatic cSCC
🔊FDA Approves Xcovery's Ensacove for ALK-Positive Advanced NSCLC
🔊Organon Receives FDA Approval for Vtama Cream to Treat Atopic Dermatitis in Children and Adults
🔊FDA Approves Galderma's Nemluvio for Moderate to Severe Atopic Dermatitis
🔊Merck and Hansoh Collaborate on Obesity Treatment with Potential $2B Deal
🔊Nxera Pharma and Shionogi Launch Quviviq for Insomnia Treatment in Japan
🔊AbbVie Expands Portfolio with $200M Acquisition of Nimble Therapeutics
🔊BeiGene and CSPC Forge $150M Deal for SYH2039 in MTAP-Deleted Tumors
🔊Ottimo Pharma Raises $140M for PD-1/VEGF Dual-Targeting Cancer Treatment
🔊Lakeside Partners with Sinopharm for $1.5M Pharma Supply Agreement in China
🔊Zealand Pharma's Glepaglutide Fails FDA Approval for Short Bowel Syndrome Treatment
🔊Tonix Pharmaceuticals Secures FDA NDA Acceptance for TNX-102 SL in Fibromyalgia
🔊ARS Pharmaceuticals Launches neffy® on Express Scripts National Formularies in the US
🔊Lilly & EVA Pharma Secure Approval for Locally Produced Insulin in Egypt

🔊 AstraZeneca's Imfinzi Wins FDA Approval for Limited-Stage Small Cell Lung Cancer
🔊Govorestat's FDA Approval Denied for Classic Galactosemia
🔊EMA Approves Ozempic Label Update to Include Kidney Disease Risk Reduction
🔊MHRA Approves Delgocitinib Cream for Treating Chronic Hand Eczema in Adults
🔊Saudi Arabia Secures Over $798M in Pharmaceutical Deals at CPHI Middle East
🔊FDA Accepts Ascendis Pharma’s TransCon™ hGH sBLA for Adult Growth Hormone Deficiency
🔊Chimerix Plans NDA for Dordaviprone Targeting Aggressive Glioma
🔊Chiesi and Protalix's Dose Variation for Fabry Disease Receives EMA Validation
🔊Base Therapeutics Gains FDA IND Approval for Base-Edited NK Cell Therapy with GenScript’s Platform
🔊Tobevibart and Elebsiran Gain FDA Breakthrough Therapy Designation for Chronic Hepatitis D Virus
🔊NeuroSense Gains Positive FDA Feedback on Phase 3 Study Design for PrimeC in ALS
🔊Sanofi Gains FDA Fast Track for Dual Vaccine Protecting Seniors from Flu and COVID-19
🔊AbbVie Reports Positive Phase 3 TEMPO-2 Results for Tavapadon in Parkinson's Disease
🔊Siga's Tpoxx Falls Short in Latest Mpox Treatment Study
🔊EMA Approves ATMP Classification for NEOGAP Therapeutics' Cancer Cell Therapy pTTL

🔊 Biocon Biologics' Yesintek Receives Green Light From FDA
🔊 Gland Pharma Receives FDA Approval for Latanoprost Ophthalmic Solution
🔊 MHRA Approves LEO Pharma’s Anzupgo Cream for Chronic Hand Eczema (CHE)
🔊 Stallergenes Greer’s Palforzia Receives Positive CHMP Opinion for Treating Toddlers with Peanut Allergy
🔊 Faron Pharma’s Bexmarilimab Receives UK Innovation Passport for Blood Cancer
🔊 MHRA Grants Innovation Passport Designation to ILiAD's BPZE1 Pertussis Vaccine
🔊 Roche Expands Portfolio with $1.5B Acquisition of San Diego Biotech
🔊 PTC Secures $1B Deal With Novartis for Huntington’s Disease Drug
🔊 GSK Enters $1B Deal for Exclusive Option on DualityBio’s ADC
🔊 Intas Acquires Udenyca from Coherus in $558M Deal
🔊 Mitsubishi Tanabe Signs $480M Biobucks Deal With Dewpoint for ALS Research
🔊 Amarna Partners with NorthX Biologics to Propel Nimvec™ AM510 Development
🔊 Merus’ Bizengri Secures FDA Accelerated Approval for NRG1+ Cancers
🔊 Mesoblast’s Revascor® Earns FDA RMAT Designation for Pediatric Congenital Heart Disease
🔊 Pif’s 101-PGC-005 Receives FDA Rare Pediatric Disease Status for Systemic Juvenile Idiopathic Arthritis
🔊 FDA Awards Fast Track Status to Rigel’s R289 for Lower-Risk Myelodysplastic Syndrome
🔊 FDA Grants Fast Track Designation to Lantern's Drug LP-184 for Triple Negative Breast Cancer
🔊 Corbus’ CRB-701 Receives FDA Fast Track Designation for Relapsed Metastatic Cervical Cancer
🔊 FDA Grants Orphan Drug Designation to Exegenesis Bio’s EXG110 for Fabry Disease Treatment
🔊 FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan for Non-Small Cell Lung Cancer