Inorganic Chemical

FDA Rejects Sydnexis Myopia Drug for Kids; Chugai to Buy Renalys for $98M Upfront

2 days ago talkbio0Tagged Chugai, Complete Response Letter, methionine, Myopia, Ophthalmology specialty, Pediatric brand name, Renalys, SYD-101, Sydnexis, United States Food and Drug Administration

FDA; SYD-101; Sydnexis; myopia; pediatric; complete response letter; Chugai; Renalys; acquisition; $98M; ophthalmology

Hikal Receives US FDA Warning Letter Over Metal Contamination at Jigani Facility

1 month ago talkbio0Tagged adulteration, alpha 1-antitrypsin, Cautionary Warning, GMP violations, Hikal, India, Jigani Facility, Letter [Publication Type], Manufacturer, Metals, pharmaceutical manufacturing, Regulatory Compliance, United States Food and Drug Administration

Hikal; FDA warning letter; metal contamination; API manufacturer; GMP violations; Jigani facility; India; pharmaceutical manufacturing; regulatory compliance

American Academy of Pediatrics Breaks with RFK Jr., CDC on COVID Vaccines for Kids

2 months ago talkbio0Tagged Academy of Pediatrics, antiarrhythmic peptide, Centers for Disease Control and Prevention (U.S.), Child, COVID19 (disease), Immunization, Pediatric brand name, Policy, public health guidance, Robert F. Kennedy, Vaccines

American Academy of Pediatrics; AAP; COVID-19 vaccine; children; CDC; Robert F. Kennedy Jr.; pediatric immunizations; public health guidance; vaccine policy

FDA may not renew Pfizer’s pediatric COVID-19 shot authorization, creating uncertainty for fall child vaccinations

2 months ago talkbio0Tagged Advice, authorization, Centers for Disease Control and Prevention (U.S.), Child, Comparison, COVID19 (disease), EUA, Eua (gastropod), Moderna, Pediatric brand name, Pfizer-BioNTech, Regulatory Framework, renewal, United States Food and Drug Administration, Vaccination, Vaccines

FDA; Pfizer-BioNTech; pediatric COVID-19 vaccine; EUA renewal; authorization not renewed; child vaccinations; fall 2025; regulatory framework; Moderna comparison; CDC guidance