We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
This edition of Quick Notes focuses on congressional urging for approval of MDMA for PTSD and FDA approvals for J&J’s tuberculosis treatment Sirturo, a biosimilar for Eylea, a Stelara biosimilar and accelerated approval for Epkinly. Read More
This edition of Quick Notes looks at FDA approvals and clearances for devices involving digital pathology images, implantable device protective pockets, and measurement/monitoring systems for obstetrical and cardiac care. Read More
This edition of Quick Notes features announcements of Merck’s acquisition of EyeBio, J&J’s agreement with Numab Therapeutics, Becton Dickinson’s acquisition of Edwards Lifesciences Critical Care product group and Boston Scientific’s purchase of Silk Road Medical. Read More
In this edition of Quick Notes EU, we take a peek at new advice regarding phthalates in medical devices, advice for drugmakers facing shortage woes and Finland’s worry over the deadly side effects of a painkiller. Also, when is an orphan device an orphan? Read More
In this edition of Quick Notes, Akili snags approval for a video game-based ADHD treatment, Johnson & Johnson’s orthopedics unit wins FDA authorization for a partial knee replacement robotic-assist system, Getinge secures 510(k) clearance for clinical decision support software used to improve patient outcomes, and Philips implants the first patient with its Duo Venous stent system for a type of cardiovascular disease. Read More
This edition of Quick Notes focuses on FDA approvals for expansion of the age allowed for a treatment for muscular dystrophy, an expanded age indication of an RSV vaccine, a next-generation tyrosine kinase inhibitor (TKI) for certain solid tumors, a drug for certain thyroid cancers and an autoinjector for adults with moderate-to-severe atopic dermatitis. Read More
In this issue of Quick Notes, we provide an eyebrow-raising peek at the European Medicines Agency’s newly announced 2025 marketing authorization fees as well as some insight on how the EU wants to ensure a steady supply of medical radioisotopes and two new Q&A docs — one for biosimilars and one for medical devices that incorporate a medicinal product. Read More
This edition of Quick Notes focuses on FDA drug approvals of Farxiga for children with type 2 diabetes, Rytelo for myelodysplastic telomerase, Klisyri expanded for actinic keratosis, and Iqirvo for primary biliary cholangitis. Read More
This edition of Quick Notes offers news on medical devices including two continuous glucose monitoring system clearances for Abbott, cybersecurity vulnerabilities for Baxter Welch Allyn, clearance of an AI solution from Heuron to alert of impending intracranial hemorrhage and clearance of an easy-to-use EEG system from Zeto. Read More
This edition of Quick Notes focuses on FDA drug approvals for relapsed or refractory lymphoma, a nighttime non stimulant liquid ADHD treatment for children, extensive-stage non-small cell lung cancer and an mRNA vaccine for RSV. Read More
This edition of Quick Notes looks at the FDA clearances for heart monitoring and lung disease diagnostic algorithms, an artificial pancreas app and a bipolar radiofrequency hysteroscopy system. Read More
This edition of Quick Notes features announcements of Takeda, Abbvie and Novo Nordisk drug development collaborations and J&J’s acquisition of Proteologix. Read More