loan license to obtain in India, medical device manufacturers must adhere to regulatory requirements. A loan license in the context of medical devices involves an arrangement where a company without manufacturing capabilities can partner...
Curie.Bio Secures $380M in Series A Funding to Advance Biotech Startups to Clinical Stage Curie.Bio incubator has successfully secured $380 million for its latest fund, aimed at supporting startup companies as they progress toward...
Patent: How Pfizer, Bristol Myers Squibb, and Johnson & Johnson Are Addressing Patent 2024 Expirations Patent: The pharmaceutical industry is confronting a significant patent cliff, with the potential loss of hundreds of billions in...
5 Key FDA Decisions to Keep an Eye on in the Latter Half of 2024 5 Key FDA Decisions :This year has been notable for numerous significant FDA approvals. These include the first tumor-infiltrating...
Dr. Yusuf Hamied: How an Indian Entrepreneur Challenged Big Pharma to Offer AIDS Medications at $1 a Day Dr. Yusuf Hamied of Cipla was an avid reader of medical journals, spending over $150,000 annually...
Regulatory affairs in clinical research are vital, ensuring trials comply with rules for patient safety and effective treatments. Introduction to Regulatory Affairs in Clinical Research Regulatory affairs are crucial for guaranteeing pharmaceutical products and...
Sarepta Gains Complete Approval and Expanded Label for DMD Gene Therapy Sarepta The FDA announced on Thursday that Sarepta Therapeutics’ gene therapy Elevidys will now be available to Duchenne muscular dystrophy (DMD) patients aged...
Spikevax Modernas latest COVID vaccine outperforms the current shot in a crucial efficacy trial involving adults. Spikevax Moderna latest COVID vaccine announced on Thursday that its upcoming COVID-19 vaccine showed higher effectiveness in adults...
Medical Devices / News Articles
by samitfm · Published June 14, 2024 · Last modified January 8, 2025
Clarios SpiroSphere® with wireless ECG- FDA clears, simplifying clinical trial data collection. Clarios SpiroSphere The FDA has granted 510(k) clearance for the COR-12 wireless ECG device, now seamlessly integrated with SpiroSphere®. This integration enables...
Medical Devices / News Articles
by samitfm · Published June 14, 2024 · Last modified January 8, 2025
DSCSA (Drug Supply Chain Security Act): FDA extends on 24 DSCSA tracking rules for small dispensers by two years and allows exemption requests. DSCSA (Drug Supply Chain Security Act): On Wednesday, the US Food...
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