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Avobis Bio’s lead therapeutic, AVB-114, has received FDA’s RMAT designation for Crohn’s perianal fistulas, building on its Fast Track status to accelerate development with enhanced regulatory support and guidance.
FDA | 06/10/2025 | By Dineshwori | 150
FDA Announces New ANDA Prioritisation Pilot to Support US Generic Drug Manufacturing and Testing
More than half of pharmaceuticals distributed in the US are manufactured overseas. Further, the US is reliant on overseas sources for Active Pharmaceutical Ingredients (APIs). As of 2025, only nine percent of API manufacturers are in the US, compared to 22 percent in China and 44 percent in India.
FDA | 06/10/2025 | By Dineshwori
FDA Introduces Pilot Scheme to Simplify Nicotine Pouch Manufacturers' Research Obligations
The U.S. Food and Drug Administration (FDA) is set to ease research requirements for manufacturers of nicotine pouches under a new pilot scheme, according to internal meeting transcripts. This marks the clearest indication yet of a more relaxed approach to smoking alternatives.
FDA | 22/09/2025 | By Darshana | 172
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 | 238
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 | 623
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 | 455
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 | 772
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 | 451
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 | 664
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 | 473
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