Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination ...

ST. PAUL, Minn. & ST. LOUIS--(BUSINESS WIRE)--Kindeva Drug Delivery (“Kindeva”) and Meridian Medical Technologies (“Meridian”) announced today the completion of the transaction to combine the two ...

The U.S. Food and Drug Administration plans to integrate virtual testing and computer modeling into the regulatory approval process for manufacturers, the agency revealed in a proposed work plan ...

Whole process simulation method gives drug firms more information about process equipment-related leachables—PERLs, say developers.

Shares of Lyra Therapeutics Inc. soared more than 310% on data from its second phase III trial testing drug-device candidate LYR-210 in patients with chronic rhinosinusitis, with results from the ...

Maetrics, a leading international life sciences regulatory and compliance consultancy, has launched a new whitepaper on the adaptations and additions to the EU Medical Device Regulation (MDR) ...

Dublin, July 10, 2025 (GLOBE NEWSWIRE) -- The "Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course" ...

Credit: Getty Images. VP-102 is a drug-device combination product that delivers cantharidin (0.7% w/v) via a single-use applicator. The Food and Drug Administration (FDA) has accepted for review the ...