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Sanofi Secures FDA Breakthrough Designation for Rare Disease Therapy
Sanofi has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its investigational drug venglustat, aimed at treating neurological symptoms associated with type 3 Gaucher disease (GD3).
FDA | 19/03/2026 | By Darshana | 146
US FDA Advances Review of Tzield in Young Children
The FDA has accepted Sanofi’s sBLA for Tzield under priority review, seeking broader pediatric use in delaying type 1 diabetes onset.
FDA | 06/01/2026 | By News Bureau | 149
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 | 394
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 | 284
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 | 162
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 | 298
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 | 458
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 | 883
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 | 593
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 | 1058
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