United States Food and Drug Administration – Page 26

FDA Reverses Course, Rehires Hundreds of Recently Fired Probationary Workers

6 months ago talkbio0Tagged Department of Health and, federal agencies, HHS, mass layoffs, probationary workers, Transplant Registry Unified Management Program, United States Food and Drug Administration

FDA, probationary workers, rehiring, mass layoffs, federal agencies, Trump administration, Department of Health and Human Services (HHS)

FDA Approves Mirum’s Ctexli as First Treatment for Rare Lipid Disorder CTX

6 months ago talkbio0Tagged Approved, bile acid therapy, cerebrotendinous xanthomatosis, chenodeoxycholic acid, Ctexli, CTX, Lipoidosis, Metabolic Diseases, Mirum, United States Food and Drug Administration, Xanthomatosis, Cerebrotendinous

Ctexli, chenodiol, cerebrotendinous xanthomatosis (CTX), FDA approval, Mirum Pharmaceuticals, rare metabolic disorder, lipid storage disease, bile acid therapy

BridgeBio’s Attruby Gains FDA Approval, Challenging Pfizer’s Tafamidis in ATTR-CM Treatment

6 months ago talkbio0Tagged Acoramidis, Approved, ATTR-CM, Attruby, BridgeBio, Cardiomyopathies, Pfizer, Prealbumin, Stabilizer - function, tafamidis, United States Food and Drug Administration

Attruby, acoramidis, BridgeBio, ATTR-CM, tafamidis, Pfizer, FDA approval, transthyretin stabilizer, cardiomyopathy

GSK’s Penmenvy Approved: New 5-in-1 Meningococcal Vaccine Enters U.S. Market

6 months ago talkbio0Tagged Approved, Invasive meningococcal disease, MenABCWY, Meningococcal vaccine, Penmenvy, SmithKline Beecham, United States Food and Drug Administration, Vaccines

Penmenvy, GSK, meningococcal vaccine, FDA approval, 5-in-1 vaccine, MenABCWY, invasive meningococcal disease (IMD)

Bavarian Nordic’s Vimkunya Approved by FDA as First Chikungunya Vaccine for Ages 12 and Up

6 months ago talkbio0Tagged Adolescent (age group), Approved, Bavarian Nordic, chikungunya vaccine, traveler, United States Food and Drug Administration, Vaccines, Virus-Like Particle, Vimkunya

Vimkunya, chikungunya vaccine, Bavarian Nordic, FDA approval, virus-like particle vaccine, adolescents, travelers

FDA Approves Ono Pharmaceutical’s Romvimza for Rare Joint Tumor

6 months ago talkbio0Tagged Approved, Cancer Therapeutic Procedure, Deciphera acquisition, Dosage Forms, Fibrous histiocytoma of tendon sheath, Infrequent, Romvimza, tenosynovial, United States Food and Drug Administration

Romvimza, tenosynovial giant cell tumor (TGCT), FDA approval, Ono Pharmaceutical, Deciphera acquisition, kinase inhibitor, rare cancer treatment

FDA Approves Ono’s Romvimza for Rare Joint Tumor, Challenging Daiichi Sankyo’s Turalio

7 months ago talkbio0Tagged Approved, CSF1, CSF1 gene, Daiichi, Dosage Forms, Fibrous histiocytoma of tendon sheath, Giant Cell Tumors, Inhibitor, Joint Tumor, Romvimza, Sankyo, tenosynovial, Turalio, United States Food and Drug Administration, Vimseltinib

Romvimza, vimseltinib, tenosynovial giant cell tumor (TGCT), Ono Pharmaceutical, FDA approval, Daiichi Sankyo, Turalio, CSF1 inhibitor, rare joint tumor

GSK’s Penmenvy Gains FDA Approval, Joining Pfizer in 5-in-1 Meningococcal Vaccine Market

7 months ago talkbio0Tagged Adolescent (age group), Approved, Invasive meningococcal disease, Meningococcal vaccine, Penmenvy, Pfizer, SmithKline Beecham, United States Food and Drug Administration, Vaccines, Young Adult

Penmenvy, GSK, FDA approval, meningococcal vaccine, 5-in-1 vaccine, Pfizer, Penbraya, invasive meningococcal disease (IMD), adolescents and young adults