News about "FDA"

Novartis Breaks Ground on Flagship Manufacturing Hub in North Carolina

Novartis has officially begun construction of its flagship manufacturing hub in North Carolina, reinforcing its commitment to end-to-end production of key medicines for US patients. The project, highlighted by FDA Commissioner Marty Makary and Governor Josh Stein, underscores Novartis’ ongoing investment and growth in the US pharmaceutical sector.

FDA | 15/12/2025 | By News Bureau

FDA Grants RMAT Designation to Avobis Bio's Implantable Cell Therapy AVB-114 for Crohn's Perianal Fistulas

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 |  235

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 |  104

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 |  229

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 |  315

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 |  708

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 |  486

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 |  883

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 |  507

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 |  741