SI-BONE Announces FDA Clearance For Expanded Rod Compatibility With The iFuse Bedrock Granite Implant System
SI-BONE, Inc., (NASDAQ:SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, today announced an additional FDA clearance for iFuse Bedrock
BrainStorm Cell Therapeutics Announces Type A Meeting With FDA Granted For NurOwn; Meeting Scheduled For Jan. 11, 2023
NEW YORK, Dec. 27, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the U.S.
Junshi Biosciences and Coherus Announced FDA Has Been Unable to Travel to China to Conduct the Required Site Inspection Resulting in Delayed Action on the BLA for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma
Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) today announced that the companies have not received an action letter from the U.S.
Acer Therapeutics Receives FDA Approval for Type 5 – New Formulation or New Manufacturer of OLPRUVA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214860
Roche’s Follicular Lymphoma Therapy Scores FDA Approval
The FDA approved Roche Holding AG (OTC:RHHBY) unit Genentech’s Lunsumio (mosunetuzumab-axgb) for relapsed or refractory (R/R) follicular lymphoma (FL) after two or more…
Biofrontera Has Received A Notice Of Allowance For Its U.S. Patent Application 17/269,816 Titled “Photodynamic Therapy Comprising Two Light Exposures At Different Wavelengths (For The Prevention Or Treatment Of Dermatological Disease)”
https://patentcenter.uspto.gov/applications/17269816/ifw/docs
Valneva Concludes FDA Regulatory Submission For One-Shot Chikungunya Vaccine
Valneva SE (NASDAQ:VALN) completed a rolling regulatory submission step with the FDA for its single-shot chikungunya vaccine candidate, VLA1553, in persons…
DBV Technologies Shares Jumps As FDA Lifts Partial Hold On Pivotal Trial For Peanut Allergy Patch
The FDA has lifted the partial clinical hold on DBV Technologies (NASDAQ:DBVT) VITESSE Phase 3 clinical trial that will evaluate the modified…
Immutep Announced on Thursday, Successful Meeting With the FDA on Eftilagimod Alpha Plus Chemotherapy for the Treatment of Metastatic Breast Cancer
Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the results of a positive follow-up Type C meeting with the US Food and Drug Administration (FDA) regarding late-stage clinical development plans for its first-in-class soluble LAG-3 pr