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News about "FDA"
US FDA Accepts BioMarin's sNDA for VOXZOGO in Achondroplasia
The US Food and Drug Administration (FDA) has accepted BioMarin's sNDA for VOXZOGO in achondroplasia, supported by long-term safety and efficacy data, including adult height, body proportionality, and arm span outcomes.
FDA | 14/07/2026 | By News Bureau
US FDA Proposes New Rule to Modernise Drug Manufacturing Registration
The US Food and Drug Administration (FDA) has proposed a new rule to modernise drug manufacturing registration, streamline advanced distributed manufacturing, and improve visibility into foreign drug supply chains.
FDA | 13/07/2026 | By News Bureau
US FDA Expands OTC Access to Naloxone Nasal Spray for Opioid Overdose
US FDA expands Over-the-Counter (OTC) access to naloxone nasal spray for opioid overdose, supporting efforts to prevent overdose deaths and strengthen addiction recovery initiatives under the US government’s public health strategy.
FDA | 18/06/2026 | By News Bureau
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 | 162
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 | 169
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 | 408
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 | 303
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 | 177
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 | 310
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 | 481
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