Highlights
BRIEF—Collategene sales rights deal terminated in Japan and the USA
Mitsubishi Tanabe Pharma announced the termination of its exclusive sales rights agreements with AnGes for the HGF gene
Regulatory Update — Week of Aug. 19, 2024
nl This week, the FDA published final guidance on product-specific guidance meetings between FDA and ANDA appli
Quick Notes: EU Edition — Aug. 23, 2024
nl In this edition of Quick Notes EU, we note a revised EMA guideline on pharmacovigilance, a call by EMA to re
Lack of CAPAs, MDRs, Complaint Follow-Up, Earn Globus a Warning Letter
nl Globus Medical, a manufacturer of surgical robots, received an FDA Warning Letter after the company’s
FDA Finalizes Guidance on Electronic Submissions for De Novo Devices
nl The FDA outlines what goes into a De Novo device request filed using the electronic Submission Template and
J&J gains EC approval for Balversa
The European Commission (EC) has approved Balversa (erdafitinib) from US healthcare giant Johnson & Johnson in bladder c
EC approval for Moderna’s RSV vaccine mRESVIA
Moderna today received approval from the European Commission (EC) for its mRESVIA (mRNA-1345), an mRNA respiratory syncy
US FDA panel to review approach to checkpoint blockers
The US Food and Drug Administration (FDA) has scheduled a public meeting of key scientific advisors to discuss the use o
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US pricing watchdog says Rytelo is too expensive
The Institute for Clinical and Economic Review (ICER) has published its final evidence report evaluating the clinical ef
Association for Medical Education in Europe AMEE 2024 conference
The conference will be held in Basel, Switzerland from 26-28 August
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