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In this edition of Quick Notes, AstraZeneca nabs a new indication for a severe asthma drug, Alvotech and Teva win FDA approval for a Stelara biosimilar, Takeda secures approval for a maintenance therapy for Crohn’s disease, Lumicell’s drug-device imaging combination for breast cancer wins regulatory clearance, and Roche’s lung cancer adjuvant therapy snags an FDA nod. Read More
Stagnant liquid inside an air purification unit, hundreds of complaints on tablet counts and inadequate guidance to call centers are but a few of the litany of issues outlined in the FDA’s Form 483 levied on India-based Sun Pharmaceuticals. Read More
To detect, prevent and manage medicine shortages in the EU and European Economic Area (EEA), the European Medicines Agency (EMA) will create a new system to gather information about medicine supply and demand. Read More
The fact that China manufactures almost all of the active pharmaceutical ingredients (API) used to make drugs for Americans could be a threat to national security, according to FDA Commissioner Robert Califf. Read More
The FDA’s CDRH 2024 safety and innovation reports tout how the center has updated its 2018 Medical Device Safety Action Plan and regulated evolving technologies while working to make the U.S. market more innovative for devicemakers. Read More
The FDA Oncology Center of Excellence has announced Project Asha, an initiative in collaboration with the White House Cancer Moonshot Program to increase oncology clinical trial access in India. Read More
The European Medicines Agency (EMA) has released a document detailing how the agency’s real-world evidence (RWE) office can help with medical research. Read More
Fake Botox has sent nine people to the hospital and caused harmful reactions in 10 others, prompting an FDA investigation and a warning about counterfeit forms of the neurotoxin from the CDC. Read More