AstraZeneca’s Soliris Gains Approval for Pediatric Generalized Myasthenia Gravis in Japan
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received an...
Pediatric drugs
Pfizer and BioNTech Receive Positive CHMP Opinion for Comirnaty Vaccine
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
Roche’s Evrysdi Receives EC Approval for Expanded Indication in Infants with SMA
Swiss pharmaceutical giant Roche (SWX: ROG) has received regulatory approval from the European Commission (EC)...
China Releases Third List of Pediatric Drugs to Guide Development and Filings
The National Health Commission (NHC), National Healthcare Security Administration, National Medical Products Administration (NMPA), and...
Pfizer’s RSV Vaccine Abrysvo Receives European Commission Approval for Maternal Immunization
Pfizer (NYSE: PFE) has received registration approval from the European Commission (EC) for its respiratory...
Pfizer’s RSV Vaccine Abrysvo Receives FDA Authorization for Maternal Immunization
The US Food and Drug Administration (FDA) has authorized the use of Pfizer’s (NYSE: PFE)...
CanSino BiologicsLaunches Phase III Trial for DTcP Vaccine in Infants and Young Children
CanSino Biologics Inc. a leading China-based vaccines specialist (HKG: 6185), has announced the initiation of...
GSK Partners with LimmaTech for Further Development of Quadrivalent Shigellosis Vaccine
UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) has licensed its quadrivalent bioconjugate shigellosis vaccine candidate...
Pfizer’s GBS Vaccine Candidate GBS6 Shows Promise in Phase II Maternal Immunization Study
Pfizer (NYSE: PFE) has this week published the Phase II data for its Group B...
Janssen’s Sirturo (Bedaquiline) Expands Indication to Include Adolescents with MDR-TB
The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced that the National...
Sanofi and AstraZeneca Receive FDA Approval for RSV Prevention Treatment Beyfortus
France-based Sanofi (NASDAQ: SNY) has announced that it, along with AstraZeneca (AZ; NASDAQ: AZN), has...
Chile Expands Financial Coverage for AbbVie’s RSV Prophylaxis Synagis
Chile’s Ministry of Health (MINSAL) has announced an immediate expansion in the coverage under its...
China’s NAFR Enhances Tax Benefits for Private Health Insurance Purchases
The National Administration of Financial Regulation (NAFR) in China has issued a Notification indicating that...
CDE Launches Trial Procedures for Adding Pediatric Information to Drug Inserts
The Center for Drug Evaluation (CDE) has released the “Work Procedures for Adding Children’s Drug...
China Medical System’s Diazepam Nasal Spray Receives NMPA Approval for Cluster Seizures
China-based China Medical System Holdings Ltd (CMS; HKG: 0867) has announced receiving New Drug Application...
NMPA Issues Procedures for Enhancing Children’s Medication Information in Drug Inserts
The National Medical Products Administration (NMPA) has released the “Procedures for Adding Children’s Medication Information...
China’s NHC Releases Fourth List of Pediatric Priority Drugs to Boost Development
The National Health Commission (NHC) of China has published its fourth list of pediatric drugs...
Roche’s Rozlytrek on Track for Priority Review for Pediatric NTRK Fusion Tumor Treatment
The Center for Drug Evaluation (CDE) website has indicated that Roche’s (SWX: ROG) Rozlytrek (entrectinib)...
CDE Lists Three Home-Grown Drugs for Priority Review, Including Myopia Treatment
The Center for Drug Evaluation (CDE) website has indicated that three home-grown drugs are on...
Sanofi’s VaxigripTetra Expands Influenza Vaccine Access to All Ages in China
French pharmaceutical company Sanofi (NASDAQ: SNY) has announced that its tetravalent influenza virus split vaccine,...