USFDA approves expanded age indication for GSK’s RSV vaccine ‘Arexvy’
Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes
Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes
Approval based on results from T2NOW, one of the largest paediatric type-2 diabetes Phase III trials to date
Data support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted therapy for COPD
Wacker Biotech US, a wholly owned subsidiary of Wacker Chemie AG, specializes in the microbial production of pDNA
With this, for all our USFDA facilities, EIRs are in place
Submission based on results from pivotal phase III trial showing all primary endpoints met
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
This facility manufactures APIs & formulations of oncology and non-oncology products.
Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2
The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
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