The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc.’s emergency authorization request for the company’s COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc.’s vaccine for those aged 6 months through 4 years.
The U.S. Food and Drug Administration issued a partial clinical hold for Foghorn Therapeutics’ Phase I clinical study, investigating the safety and efficacy of FHD-286 in patients with relapsed and/or refractory acute myelodysplastic leukemia (AML) and myelodysplastic syndromes (MDS). The hold follows a serious adverse event in which a study participant died after developing possible differentiation syndrome.
Abbott Laboratories and the U.S. Food and Drug Administration are on track to reopen the company’s Sturgis, Michigan, baby formula manufacturing plant within one or two weeks, FDA Commissioner Robert Califf said on May 19.
U.S. FDA authorizes Pfizer’s COVID booster shot for young children
BNT162b2 (Pfizer and BioNTech), Children 5-11 Years, Coronavirus Disease (COVID-19) Pandemic, COVID-19 booster shots, COVID-19 shots, COVID-19 Vaccinations, COVID-19 Vaccines, Emergency Use Authorization (EUA), FDA, Pandemics, Pediatric, Pediatric Vaccines, Pfizer, Therapeutics, VaccinationsThe U.S. Food and Drug Administration on May 17 authorized the use of a booster shot of Pfizer and BioNTech’s COVID-19 vaccine for children aged 5 to 11, making everyone in the United States over the age of 5 eligible for a third shot.
BridgeBio augments comeback week with sale of priority review voucher
Bristol Myers Squibb, Business, FDA, Layoffs, Molybdenum cofactor deficiency (MoCD) Type A, PDUFA, Priority Review, Priority Review Status, Priority Review Voucher, Rare Diseases, Rare Pediatric Disease Priority Review Voucher, Sales, TherapeuticsOne day after BridgeBio Pharma struck a nearly $1 billion oncology pact with Bristol Myers Squibb, the California-based company announced plans to sell a priority review voucher received in February.
UCB psoriasis drug will need to wait for US approval
Autoimmune Diseases, Biologics License Application (BLA), Complete Response Letter, FDA, Generalized Myasthenia Gravis (gMG), Humanized IgG1 monoclonal antibody, Immune-Mediated Diseases, Immunotherapeutics, Immunotherapies, Inflammatory Diseases, Lesions, Monoclonal Antibodies, Plaque Psoriasis, Plaque Psoriasis, Plaque Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis Lesions, Scalp plaque psoriasis, Scalp Psoriasis, Skin Diseases, Therapeutics, UCBThe U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.
LogicBio Therapeutics was granted the green light to continue dosing participants in the company’s Phase I/II Sunrise trial investigating the safety of LB-001 in patients with methylmalonic acidemia (MMA), characterized by methylmalonyl-CoA mutase (MMUT) gene mutations.
Less than one month after the U.S. Food and Drug Administration raised concerns about the supplemental New Drug Application for Pfizer and Myovant Sciences’ Myfembree (relugolix), the regulatory agency extended the review period to Aug. 6. The initial approval review date was May 6.
Bayer’s Nubeqa drug won priority review status from the U.S. Food and Drug Administration, as the German drugmaker seeks to widen the use of the prostate cancer drug from an early disease stage to metastatic cases.
U.S. FDA declines to approve two more China-tested drugs
Business, China, Complete Response Letter, FDA, FDA Statements, Gastroenteropancreatic Neuroendocrine Tumors, Gastroenteropancreatic neuroendocrine tumors, Gastrointestinal Tumors, Lung Neuroendocrine Tumors, Nasopharyngeal Carcinoma (NPC), Neuroendocrine Tumors, Oncology, R&D, Shares, Therapeutics, Throat CancerThe U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies – Hutchmed Ltd. – needs to test its drug for the U.S. population in a diverse multi-regional trial.