News
AutoIVF Publishes Peer-Reviewed Nature Medicine Study Evaluating Oocyte Recovery Variability in IVF Using an Automated Microfluidic System
3+ hour, 15+ min ago (337+ words) The publication addresses a long-standing aspect of IVF laboratory practice: the reliance on manual visual screening to identify oocytes in follicular fluid. While substantial advances have occurred in downstream IVF laboratory processes, the initial egg identification step has remained largely…...
Kyowa Kirin Could Get Windfall From Updated Newborn Screening Recommendations
1+ mon, 3+ week ago (299+ words) Earlier this week, Kennedy added metachromatic leukodystrophy (MLD) and Duchenne muscular dystrophy to the list of diseases included on the federal government's Recommended Uniform Screening Panel (RUSP), a list of diseases that the Department of Health and Human Services (HHS) suggests…...
CDC Formally Adopts Delayed Hepatitis B Vaccine Dose
1+ mon, 3+ week ago (642+ words) The CDC has accepted the recommendation of its vaccine advisory committee and ended the three-decade-long practice of giving most newborn children a birth dose of the hepatitis B vaccine. The change in recommendation, announced Tuesday, leaves the decision of whether…...
FDA Launches Probe Into Safety of Approved Anti-RSV Antibodies
2+ mon, 2+ day ago (222+ words) The FDA is looking into two approved antibodies used to prevent respiratory syncytial virus infections in babies, continuing its recent inquiry into the safety of pediatric preventative agents. Specifically, the agency is reviewing the safety of Sanofi and AstraZeneca's Beyfortus…...
FDA Revives Decades-Dormant Drug as Potential Autism Treatment
4+ mon, 2+ week ago (332+ words) The FDA on Monday took the highly unusual step of initiating the reapproval of GSK's Wellcovorin, seeking to bring the drug back after 25 years off the market as a potential treatment for autism symptoms. The regulator has kicked off the…...
FDA Expert Panels Lack Balance in Pursuit of ‘Gold Standard Science’
5+ mon, 4+ day ago (603+ words) Earlier this summer, the FDA convened an expert panel to weigh the benefits and risks introduced by selective serotonin reuptake inhibitor use during pregnancy. However, the discussion immediately drew controversy due to the near unanimity of panelists critical of SSRIs,…...
Regeneron’s Gene Therapy Restores Hearing in Patients with Rare Genetic Deafness
11+ mon, 2+ week ago (500+ words) Regeneron's gene therapy DB-OTO has restored partial hearing in 10 of 12 children with profound otoferlin-related deafness, a genetic condition researchers say is a perfect match for gene therapy. The Phase I/II data, shared Monday afternoon at the Association for Research…...