Dupixent by Sanofi and Regeneron Approved by FDA for Eosinophilic Esophagitis in Younger Pediatric Patients
The US Food and Drug Administration (FDA) has concluded a priority review and granted approval...
Pediatric drugs
Eli Lilly’s Subsidiary Akouos Reports Positive Preliminary Results for Gene Therapy in Hearing Loss
Eli Lilly (NYSE: LLY) has announced preliminary results from a Phase I/II study conducted by...
Drug Farm’s DF-003 Earns FDA Rare Pediatric Disease Designation for ROSAH Syndrome
Sino-US biotech company Drug Farm has announced that it has received Rare Pediatric Disease Designation...
China’s NHC Unveils Strategy to Enhance Pediatric Healthcare by 2025
The National Health Commission (NHC) has issued a set of Opinions aimed at “Promoting the...
Thederma’s TAP-1503 Cream Receives Priority Review Status for Pediatric Atopic Dermatitis Treatment in China
The Center for Drug Evaluation (CDE) website has indicated that China-based Thederma’s TAP-1503 cream is...
EMA’s CHMP Gives Green Light to Sanofi’s Fexinidazole for Acute Sleeping Sickness Treatment
Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...
Vertex Pharmaceuticals and CRISPR Therapeutics Receive Conditional Approval for CRISPR Gene-Editing Therapy
Vertex Pharmaceuticals (NASDAQ: VRTX) and CRISPR Therapeutics (NASDAQ: CRSP) have received conditional approval from the...
Roche’s Gene Therapy Elevidys Misses Primary Endpoint in DMD Trial
Switzerland-headquartered pharmaceutical giant Roche (SWX: ROG) has announced that a Phase III trial for its...
Pfizer’s Penbraya Receives FDA Approval for Meningococcal Immunization
Pfizer Inc. (NYSE: PFE) announced last week that it has successfully registered its pentavalent meningococcal...
Bayer Partners with HALO Precision Diagnostics to Develop Gadoquatrane for MRI Applications
Germany-based Bayer (ETR: BAYN) has announced a strategic partnership with US radiology expert HALO Precision...
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...
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)...