Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accropeutics, Applied Therapeutics, Celltrion, Dyne, Hibio, Janssen, Legend, Pfizer, Sandoz.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adamis, Biontech, DMK, Intercept, Madrigal, Pfizer.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annexon, Antabio, Apellis, Bial, Bioinvent, Bioxcel, Harmony, Immutep, Jaguar, Lynk, Onconova, Stallergenes, Stemcyte, Topas, Transgene, Vanda.

The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus pandemic. They are available for free with registration. Note that we have added three critical tables, which are continuously updated:

Vaccines and therapeutics in development
Diagnostics with U.S. FDA emergency use authorization
Clinical trials of biopharma products affected by COVID-19

Pfizer Inc.’s Paxlovid (nirmatrelvir/ritonavir) became the first oral antiviral to win full U.S. FDA approval for treating COVID-19, cleared for use in adults who are at high risk for progression to severe disease, including hospitalization or death. The nod follows two months after the agency’s Antimicrobial Drugs Advisory Committee voted 16-1 in favor of Paxlovid’s overall benefit-risk assessment.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerami, Allgenesis, Alimera, Alzecure, Clarity, Curium, Cybin, Daiichi, Eloxx, Galapagos, Geovax, Immunos, Immutep, Innovative Cellular, Lassen, Lisata, Mereo, Peptilogics, Pliant, PTC, Quoin, Thermosome, Trialspark.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aiviva, Alnylam, Alpine, Anixa, Apnimed, Atyr, Bridgebio, Candel, Corium, Hanall, Hepion, Immix, Medincell, Milestone, Mink, Mirum, Neurimmune, Novartis, Novo Nordisk, Rain, Redhill, Regeneron, Salubris, Vicore.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alligator, Antengene, Galera, Immupharma, Pepgen, Vifor, Westvac.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aravive, Astellas, Bayer, Bioartic, Bionxt, Biophytis, Cabaletta, Cormedix, Eisai, Kamada, Kimera, Orchard, Phio, Sarepta, Virios, YS.