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News about "FDA"
American Injectables Secures FDA Approval
American Injectables, specialising in sterile injectables, has announced that it has received FDA approval.
FDA | 10/01/2025 | By Abha
FDA Approves Nasal Spray Influenza Vaccine for Caregiver Administration
FluMist is approved for preventing influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age.
FDA | 21/09/2024 | By Aishwarya | 145
Indica Labs and Hamamatsu Photonics Receive FDA Clearance for HALO AP Dx Digital Pathology Platform
HALO AP Dx is indicated for the primary diagnosis of surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue scanned by the NanoZoomer® S360MD Slide scanner.
FDA | 24/05/2024 | By Abha | 118
FDA Accepts PTC Therapeutics' Application for Upstaza Gene Therapy for AADC Deficiency
The BLA acceptance comes with a Priority Review designation, highlighting the urgent need for therapeutic options for patients suffering from AADC deficiency.
FDA | 15/05/2024 | By Abha
SN Bioscience's SNB-101 Granted FDA Fast Track Designation for Small Cell Lung Cancer Treatment
SNB-101, previously designated as an orphan drug for SCLC and pancreatic cancer, has now received Fast Track designation, signaling a step towards potential commercialization following the completion of phase 2 clinical trials.
FDA | 10/05/2024 | By Abha | 133
WestGene's mRNA Therapeutic Cancer Vaccine Receives FDA Approval
This approval marks a key moment as the world's first EB virus-related mRNA therapeutic cancer vaccine to receive regulatory clearance.
FDA | 10/05/2024 | By Abha | 163
Azurity Pharmaceuticals Receives FDA Approval for Myhibbin
Mycophenolate mofetil, an antimetabolite immunosuppressant crucial in safeguarding transplanted organs from rejection by the body's immune system, is a vital medication for organ transplant recipients.
Fda | 07/05/2024 | By Abha
FDA Inaugurates CDER Center for Clinical Trial Innovation (C3TI)
FDA's Center for Drug Evaluation and Research (CDER) has launched the CDER Center for Clinical Trial Innovation (C3TI).
FDA | 16/04/2024 | By Aishwarya | 167
Strides Pharma Receives FDA Approval for Antidepressant Drug
Strides Pharma Science’s subsidiary has gained approval from the US health regulator to market a generic antidepressant medication.
FDA | 10/04/2024 | By Aishwarya | 322
Phanes Therapeutics Earns FDA Fast Track Status for Pancreatic Adenocarcinoma Treatment
Phanes Therapeutics has announced that the US Food and Drug Administration has granted Fast Track designation to PT886 for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma.
FDA | 21/03/2024 | By Manvi | 262
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