FDA
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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Sep 05, 2023
Daiichi Sankyo’s Trastuzumab Deruxtecan; ODD to Bexmarilimab for AML; Roche’ Alecensa; Ergomed Aims To Go Private; Tagraxofusp Receives ODD in Japan for BPCDN; FDA Fast Track Designation to Abliva’s KL1333
FDA Grants Breakthrough Therapy Designations to Trastuzumab Deruxtecan for HER2+ Solid Tumors, Including mCRC ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted two additional Breakthrough Therapy Designations (BTDs) in the United States for the treatment of adult patients with unresectable or metastati...
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Aug 29, 2023
FDA Approves BMS’s Reblozyl for MDS; FDA Awards Orphan Drug Designation to NXC-201; Janssen Submits Supplemental NDA for Full Approval of BALVERSA; FDA Grants Fast Track Status to ALE.C04; FDA Orphan Drug Designation to Faron’s Bexmarilimab; FDA Clears IND Application for AHB-137
FDA Approves Bristol Myers Squibb’s Reblozyl as First-Line Treatment of Anemia in Adults with Lower-Risk MDS Who May Require Transfusions Bristol Myers Squibb announced that the Food and Drug Administration (FDA) has approved Reblozyl® (luspatercept-aamt) for the treatment of anemia in adult patients with very l...
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Aug 24, 2023
Smith+Nephew’s Hip Arthroplasty System; Mammotome Launched the HydroMARK Plus Breast Biopsy Site Marker; FDA Clearance for Pioneering MARS System; CE Marks for NGS-based Test Kits; BaroPace Updated on Non-Pharmacologic Hypertension and Heart Failure Treatment Trial; Quanta Completed Enrollment in Home Run Study
Smith+Nephew Launched Hip Arthroplasty System in India On August 17, 2023, The London-based orthopedic device maker Smith+Nephew announced the launch of its OR3O dual mobility system for use in primary and revision hip arthroplasty in India. The dual mobility implants have a smaller-diameter femoral hea...
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Aug 22, 2023
Eylea HD Injection 8 Mg Approved By FDA; Veopoz Receives FDA Approval for CHAPLE Disease Treatment; FDA Places Second Partial Clinical Hold on AML Enrollment for Magrolimab Trials; FDA Approval to Incannex’s Sleep Apnoea Clinical Trial; FDA Orphan Drug Designation to Avidity’s AOC 1044; Orphan Drug Designation to CanariaBio’s MAb-AR20.5
Eylea HD Injection 8 Mg Approved By FDA for Treatment of Wet AMD, DME, and Diabetic Retinopathy The FDA has approved Regeneron Pharmaceuticals’ EYLEA HD (aflibercept) Injection of 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retin...
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