Latest FDA News
Biosimilars
The US Food and Drug Administration approved 50 novel drugs in 2024, continuing to outpace its global regulatory peers. 10 January 2025
American Pharma News
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MaaT Pharma, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases.
Latest News & Features of interest to FDA
Biotechnology
New regulatory guidance will be of interest for the increasing number of drugmakers investing ever more R&D capital into antibody-drug conjugates (ADC). 1 March 2024
Biotechnology
New information from senior executives at the US Food and Drug Administration casts light on its recent decision to apply a black box warning to certain CAR-T cell therapies. 26 January 2024
Pharmaceutical
The US Food and Drug Administration has authorized a drug importation program in Florida, as the state seeks to benefit from lower cost medicines across the border. 8 January 2024
Pharmaceutical
Artificial intelligence (AI) has become an integral part of our daily lives. Within the pharmaceutical industry, AI and machine learning (ML) are being harnessed to aid many aspects of drug development and data analysis. 27 November 2023
Pharmaceutical
In 1984, Congress passed and the President signed into law the Drug Price Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Act. 21 November 2023
Generics
The US Food and Drug Administration has revised its Manual of Policies and Procedures (MAPP), in relation to suitability petitions for generic drug regulatory submissions. 3 October 2023
Generics
Following scrutiny from Democratic senators in Congress, the US Federal Trade Commission has issued a policy statement on the proper listing of pharmaceutical patents. 18 September 2023
Generics
The US Food and Drug Administration has published product-specific guidance for generics drugmakers with the goal of facilitating pipeline development and promoting access. 19 May 2023
Pharmaceutical
While the US regulator’s scientists have given a positive opinion for Innoviva’s (Nasdaq: INVA) new antibiotic, the details appear not to have impressed investors, with shares falling 5% on Tuesday. 19 April 2023
Pharmaceutical
Amid an ongoing epidemic of opioid abuse in the USA, the country’s medicines regulator has announced safety label changes for opioids aimed at ensuring their safe use. 14 April 2023
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