AstraZeneca Reports Positive Phase III Results for Forxiga in Children with Type 2 Diabetes
UK-based AstraZeneca (AZ, NASDAQ: AZN) has announced promising results from the Phase III T2NOW study...
Pediatric drugs
Eli Lilly’s Insulin Biosimilar YouBiAn Approved for Diabetes Treatment in China
US pharmaceutical major Eli Lilly (NYSE: LLY) has announced that it has received market approval...
Cutia Therapeutics Files for Market Approval of CU-10201 with NMPA for Acne Treatment
Cutia Therapeutics (HKG: 2487), a developer focused on dermatology therapies, has announced the submission of...
CDC Provisionally Recommends Pfizer’s Abrysvo for Maternal Immunization Against RSV
The US Centers for Disease Control and Prevention (CDC) has issued a provisional recommendation for...
FDA Extends Pfizer’s Comirnaty Vaccine Indication for Omicron XBB.1.5 Variant
The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) an indication extension...
Pfizer and Valneva’s Lyme Disease Vaccine VLA15 Shows Promise as Booster in Pediatric Trials
Partners Pfizer (NYSE: PFE) and Valneva SE (NASDAQ: VALN) have revealed that their Lyme disease...
European Commission Approves Pediatric Indication for MSD’s Ervebo Ebola Vaccine
The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) approval for...
Henan Zhongshuai’s Dexmethylphenidate Hydrochloride Capsules Target Priority Review for Pediatric ADHD
Henan Zhongshuai Pharmaceutical Co., Ltd., a China-based pharmaceutical company, is poised to secure priority review...
MSD’s Gardasil 9 HPV Vaccine Demonstrates 10-Year Efficacy in Adolescents
Merck, Sharp & Dohme (MSD; NYSE: MRK) has released long-term effectiveness data for its recombinant...
Novo Nordisk’s Esperoct on Track for Priority Review in Hemophilia A Treatment
The Center for Drug Evaluation (CDE) website has indicated that Denmark-based Novo Nordisk’s (NYSE: NVO)...
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...
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...