Chocolate Recall Update As FDA Sets Concern Level
Treats were recalled after it was discovered product containing hazelnut was distributed in packaging that did not reveal the ...
Medscape1h
Inspire Medical Systems Issues Recall for Implantable Pulse Generator
Potential malfunctions after implantation can cause disruption in therapy; some patients may need revision surgery.
Sumitomo Pharma’s DSP-5336 gains FDA fast track for AML
The US Food and Drug Administration (FDA) has granted fast track designation to Sumitomo Pharma America’s (SMPA) DSP-5336 for ...
FDA warns WA residents of microdosing products linked to severe illness
The FDA says anyone with “Diamond Shruumz" products should destroy and discard them after multiple people developed severe ...
From Dr. Oz to heart valves: A tiny device charted a contentious path through the FDA
Since MitraClip, a device whose inventors include former TV personality and Pa. Senate candidate Dr. Mehmet Oz, won FDA ...
FiercePharma13h
FDA proposes cell and gene therapy site tours to help regulators learn from industry
It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become ...
Oticon scores FDA clearance for transcutaneous hearing implant
Oticon noted that the Sentio system delivers the proven benefits of its Ponto bone-anchored hearing system but in a ...
TCTMD13h
FDA to Add New Diversity Requirements for Certain Clinical Studies
Requiring sponsors to submit diversity action plans is a good first step to greater representation in trials, experts say.
Pharm Exec15h
FDA Grants Fast Track Designation to Sumitomo Pharma’s Novel Treatment for Patients with Relapsed or Refractory Acute Myeloid Leukemia
DSP-5336 targets the menin and mixed-lineage leukemia protein interaction, crucial in various biological processes, including ...
Targeted Oncology16h
FDA Receives IND Submission for Phase 1/2 Trial of Silmitasertib in Solid Tumors
The FDA has received the submission of an investigational new drug application for a phase 1/2 trial evaluating the ...
Pharm Exec16h
FDA Clears Artelo Biosciences’ Investigational New Drug Application for Chemotherapy-Induced Peripheral Neuropathy Treatment
Clearance of the New Drug Application for ART25.12 allows Artelo to begin a Phase I study for the drug in ...
Positive Outlook for Axsome’s Auvelity: ADVANCE-2 Trial and Strategic FDA Engagement Underpin Buy Rating
Leerink Partners analyst Marc Goodman maintained a Buy rating on Axsome Therapeutics (AXSM – Research Report) on July 14 and set a price ...