FDA Approvals

US Food and Drug Administration has come up with a novel draft guidance in order to further support the use of decentralised clinical trials...

Ghana Gives Go Ahead To Oxford University Malaria Vaccine

FDA Approvals

A malaria vaccine called R21/Matrix-M, which was developed in collaboration with the University of Oxford as well as a manufacturer of vaccines and immunological...

Regulatory Actions Needed For Gaps In Cancer Drug Info

FDA Approvals

Drug manufacturers are not able to provide Europeans with the required information to gauge the benefits and defects of oncology medicines. This is as...

Mid-Point Regulatory Science Strategy Study Published By EMA

FDA Approvals

The European Medicines Agency (EMA) has released a paper summarizing its Regulatory Science Strategy (RSS) mid-point achievements through 2025. Originally released in March 2020,...

WHO grants prequalification GC Biopharma’s varicella vaccine, Barycela

FDA Approvals

GC Biopharma, a leading provider of biopharmaceutical products in South Korea, announced that the World Health Organization (WHO) has granted prequalification for the company’s...

In An FDA First, Cardiac Gene Therapy Given RMAT Status

FDA Approvals

The Regenerative Medicine Advanced Therapies designation of RP-A501, which happens to be an adeno-associated virus-based gene therapy when it comes to the treatment of...

Drug Inspection Pact Between Switzerland And United States

FDA Approvals

The US and Switzerland have agreed to a Mutual Recognition Agreement (MRA) on pharmaceutical Good Manufacturing Practices (GMP). The US Food and Drug Administration (FDA)...

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