FDA
Nov 07, 2023
New Asundexian Phase III Study Result; Zibotentan/Dapagliflozin Combination Demonstrated Significant Albuminuria Reduction Chronic Kidney Disease; Orphan Drug Designation to Rhenium Obisbemeda; FDA Approves Merck’s KEYTRUDA Plus Gemcitabine and Cisplatin for Biliary Tract Cancer; Orphan Drug Designation to Ayala’s AL102; GARDP Announces Successful Phase 3 Trial of of Uncomplicated Gonorrhea
Positive Results Announced in Largest Pivotal Phase 3 Trial of a First-in-Class Oral Antibiotic to Treat Uncomplicated Gonorrhea The Global Antibiotic Research & Development Partnership (GARDP), in partnership with Innoviva, Inc. (Nasdaq: INVA), had announced a significant milestone. They revealed that zolif...
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Nov 02, 2023
Laborie Medical Acquired Urotronic; Sirtex’s LAVA Liquid Embolic System; Paige’s Cancer Detection in Breast Lymph Nodes; FDA Clearance to Neurovalens’s Non-Invasive Insomnia-Treating Device; Recor Medical’s Renal Denervation System; Pulsecare Medical’s nsPFA Clinical Trial Short-term Follow-up Results
Neurovalens Received US FDA Clearance for Non-Invasive Insomnia-Treating Device On October 30, 2023, Belfast, Northern Ireland-based Neurovalens announced the US Food and Drug Administration clearance for its Modius Sleep device meant for treating chronic insomnia. Modius has been designed to deli...
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Oct 31, 2023
Phase III RUBY Trial of Jemperli Plus Chemotherapy Updates; FDA Approves Roche’s Vabysmo for RVO; FDA Grants Priority Review to Tovorafenib Low-Grade Glioma; FDA Approves Lilly’s Omvoh; FDA Approves Toripalimab for Nasopharyngeal Carcinoma; FDA Fast Track Designation to ONCT-534 R/R mCRPC
FDA Granted Fast Track Designation to Oncternal Therapeutics’s ONCT-534 for the Treatment of Metastatic Castration-Resistant Prostate Cancer On Oct. 26, 2023, Oncternal Therapeutics, Inc. (Nasdaq: ONCT) announced that the U.S. Food and Drug Administration (FDA) has designated ONCT-534, its novel dual-acting andr...
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Oct 17, 2023
Novo Nordisk to Acquire Ocedurenone; FDA Awards Orphan Drug Designation to SLS009 in AML; FDA Approves Adjuvant Nivolumab in Completely Resected Stage IIB/C Melanoma; Fast Track Designation to South Rampart Pharma’s SRP-001; TAGRISSO + Chemotherapy Granted Priority Review in the US; Fast Track Designation to SurVaxM for Glioblastoma
South Rampart Pharma Receives U.S. FDA Fast Track Designation for SRP-001 for Acute Pain On October 12, 2023, South Rampart Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track status to its drug candidate, SRP-001, intended for the management of acute pain. SRP-001 is a...
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Oct 12, 2023
B. Braun’s Introcan Safety 2 IV Catheter; Everly Health’s At-Home Collection Kidney Health Test; FDA Clearance to Sanguina’s AnemoCheck Home; FDA Clearance for the DePuy’s TriALTIS™ Spine System; Biotronik’s Spinal Cord Stimulation Tech; Contego Medical’s Performance III Direct Transcarotid Access Stenting Trial
B. Braun Launched Introcan Safety® 2 IV Catheter with Multi-Access Blood Control Designed to Protect Clinicians Every Time the Hub is Accessed On October 11, 2023, B. Braun Medical Inc. (B. Braun), a leader in smart infusion therapy, announced the launch of its new Introcan Safety® 2 IV Catheter with Multi-Acces...
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Oct 10, 2023
Amgen to Acquire Horizon Therapeutics; Sanofi and Teva Announce Collaboration; Boehringer Obesity Drug Trial Update; FDA Places Partial Clinical Hold on IND for Lacutamab in CTCL/PTCL; Anaptys Announces Phase 3 Clinical Trial Results of Imsidolimab; Orphan Drug Designation to GC Biopharma’s GC1126A
Sanofi and Teva Announce Exclusive Collaboration to Deliver Inflammatory Bowel Disease Treatment Sanofi and Teva Pharmaceuticals, a subsidiary of Teva Pharmaceutical Industries Ltd. in the United States, have announced a collaboration to co-develop and co-commercialize asset TEV'574, which is currently in Phase ...
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Oct 03, 2023
AbbVie Presents Phase III CANOVA Study Results; Novartis’ Iptacopan Shows Promise in Phase III Study; Fast Track Designation to AVB-001 for R/R Platinum-Resistant Ovarian Cancer; FDA Issues Complete Response Letter for Lebrikizumab; Nedosiran Approveed for Primary Hyperoxaluria Type 1; Orphan Drug Designation to BDC-1001 for Gastric Cancers
AbbVie Presents Results from Phase III CANOVA Study of Venetoclax in Patients with Relapsed or Refractory Multiple Myeloma AbbVie has released findings from its Phase III CANOVA trial, which assessed the safety and effectiveness of venetoclax (marketed as VENCLEXTA®/VENCLYXTO®) in combination with dexamethasone ...
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Sep 26, 2023
LEQEMBI Intravenous Infusion Approval; Novartis’ Presented Updates on Lutathera; FDA Accepts Submission to Add PH-ILD to YUTREPIA Label; FDA Issues CRL to BLA for Pegfilgrastim-cbqv; FDA Fast Track Designation to Therpay, MWTX-003; EC Approves TEPKINLY (epcoritamab) for R/R DLBCL
Disc Medicine Receives FDA Fast Track Designation for MWTX-003 for the Treatment of Polycythemia Vera On Sept. 20, 2023, Disc Medicine, Inc. (NASDAQ: IRON) announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to MWTX-003 for the treatment of patients with Polycyt...
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Sep 12, 2023
BMS’s LPA1 Antagonist; Alnylam’s KARDIA-1 Phase 2 Study; Day One Biopharma Sought FDA Approval for Tovorafenib; EMA Orphan Drug Designation to MaaT Pharma’s MaaT033; Lundbeck and Otsuka Announce Topline Results from Two Phase III Trials of Brexpiprazole + Sertraline; Phase III CheckMate – 227 Trial Show Durable, Long-Term Survival with Opdivo Plus Yervoy
Bristol Myers Squibb’s Investigational LPA1 Antagonist Reduces Rate of Lung Function Decline in Progressive Pulmonary Fibrosis Cohort of Phase II Study BMS-986278, a potential first-in-class oral lysophosphatidic acid receptor 1 (LPA1) antagonist, was studied in patients with progressive pulmonary fibrosis (PPF)...
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Sep 07, 2023
Boston Scientific’s WATCHMAN FLX™ Pro; Quest Diagnostics’s AAV Test; Vitestro Started A.D.O.P.T. Clinical Trial; Signia Introduces Hearing Aids; Laborie Medical to Acquire Urotronic; Synchron’s Brain-Computer Interface Trial
Quest Diagnostics Granted FDA Breakthrough Designation for its Adeno-associated virus (AAV) Test On August 30, 2023, Quest Diagnostics announced that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA). The enzyme-linked immunosor...
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