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FDA approves first generic of ProAir HFA inhalation aerosol
The generic of ProAir HFA (albuterol sulfate) inhalation aerosol has been approved by the FDA to advance patient access to lower-cost medicines.
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US Food and Drug Administration (FDA)
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COVID-19 update: therapeutic and regulatory developments
European Pharmaceutical Review rounds up the latest news surrounding COVID-19, including a vaccine moving to clinical trials and the FDA's update on Chinese import inspections.
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FDA centres collaborate to evaluate conclusions of pharmacogenetic testing
The FDA has released a statement that two of its centres will collaborate to provide information on gene-drug interactions they believe have sufficient supporting evidence.
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US pharma industry leaders support blockchain tech to aid track and trace systems
A report released by pharmaceutical industry leaders in the US demonstrates how blockchain helps to track and trace prescription medicines.
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Trends in the CDMO industry for 2020
Over the past decade, the pharmaceutical industry has witnessed rapid growth in outsourcing services, driven by various factors including the growth of small molecules, increasing API complexities and the need to optimise costs. Here, Peter DeYoung shares his thoughts on the key trends he expects to see in the contract…
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Regulating heavy metals in cannabis: what can be learned from the pharmaceutical industry?
The ever-increasing demand for cannabis-based products requires US state regulators to set guidelines that ensure products are safe for human use. However, as medicinal cannabis moves forward at a rapidly increasing pace, regulations are falling behind. Here, Robert Thomas discusses the many inconsistencies across US states for monitoring levels of…
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Biotech company Promedior merges with Roche
Roche has successfully completed its purchase of Promedior, Inc. along with its entire portfolio of fibrotic disease therapeutics.
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FDA and India prevented 500 unapproved drug shipments entering US in January
A collaborative effort between the FDA and Government of India stopped shipments of illegal drugs from reaching patients in the US in Operation Broadsword.
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Voltaren approved for arthritis pain over-the-counter in the US
Voltaren Arthritis Pain has been approved by the FDA as an over-the-counter product for the temporary relief of arthritis pain.
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FDA requests market withdrawal of weight-loss drug Belviq
After clinical trials showed an increased risk of cancer in patients taking Belviq, the FDA has recommended the withdrawal of the drug from the US market.
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The importance of labelling compliance for pharma
Bart Vansteenkiste explains why it is important to validate pharmaceutical labelling compliance to ensure good manufacturing practice.
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FDA grants Priority Review to capmatinib – a targeted lung cancer therapeutic
The US Food and Drug Administration (FDA) has granted Priority Review for capmatinib, a treatment for MET exon 14 skipping mutated non-small cell lung cancer.
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Treating multi-drug resistant Mycobacterium abscessus: three’s a charm
Researchers at Aston University and Birmingham Children’s Hospital, UK, have discovered a highly effective three-drug approach to treat Mycobacterium abscessus (M. abscessus), a notoriously drug-resistant pathogen that affects up to 13 percent of cystic fibrosis (CF) patients in the UK.
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The FDA and FTC team up to prevent anti-competitive practices
The two agencies have signed a statement of their intent to combat anti-competitive practices which are preventing the adoption of biosimilars in the US drug market.
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Biologics patent expiry to positively impact US pharma, says report
New research has suggested that the expiration of biologics patents will be the factor that positively impacts US pharma the most this year.
