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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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US Food and Drug Administration (FDA)
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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.
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Multiple myeloma treatment receives IND from FDA
The FDA has granted Investigational New Drug (IND) authorisation to KP1237 for the treatment of multiple myeloma using a patient's own Natural Killer cells.
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FDA approves AUDENZ™, an adjuvanted Influenza A pandemic vaccine
The US FDA has approved AUDENZ, a vaccine formulated with MF59® adjuvant, as an Influenza A H5N1 vaccine that can be quickly deployed in the event of a pandemic.
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Efficient Laboratories Inc recalls flu treatment due to contamination
Rompe Pecho EX, Rompe Pecho CF and Rompe Pecho MAXliquid are being recalled due to microbial contamination.
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FDA approves Palforzia for treatment of peanut allergy in children
Palforzia, a peanut allergen powder, has been approved for the reduction of allergic reactions in children aged four to 17. It is not an emergency treatment but instead designed to build tolerance.
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FDA approves first interactive digital inhaler sensor
The FDA has given its first approval to an interactive digital inhaler sensor that allows patients to manage their condition by providing instructions and recording usage data.
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FDA grants priority review to selpercatinib New Drug Application
Priority review has been given to the NDA for selpercatinib to treat advanced RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.
