Serum Institute Of India - BCG Vaccine (Freeze-Dried)
Serum - Protection from birth onwards. For the prevention of Tuberculosis. 0.1 ml, Intradermal for children over one year of age and adult. A single dose of BCG vaccine is required to provide …
ImmunityBio, Serum Institute win FDA nod to combat BCG shortage
2025年2月19日 · With Merck & Co. largely propping up supplies of the bladder cancer-fighting bacteria Bacillus Calmette-Guérin (BCG) in the U.S., ImmunityBio has received the FDA all …
FDA Authorizes ImmunityBio to Provide Recombinant BCG (rBCG) …
2025年2月19日 · INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with …
ImmunityBio, Serum Institute of India Secure BCG Supply Deal for …
2024年5月2日 · Recombinant BCG (iBCG) has demonstrated potent immunogenicity with CD8+ and CD4+ stimulation and improved safety compared to standard BCG in clinical trials across …
ImmunityBio, Serum Institute of India Agree on an Exclusive …
2024年5月2日 · Recombinant BCG (iBCG) has demonstrated potent immunogenicity with CD8+ and CD4+ stimulation and improved safety compared to standard BCG in clinical trials across …
FDA Authorizes ImmunityBio to Provide Recombinant BCG as …
2025年2月23日 · On February 19, ImmunityBio, Inc. announced that the U.S. Food and Drug Administration (FDA) has authorized an expanded access program (EAP) to introduce …
How recombinant BCG could ease strain of supply issues
11 小时之前 · For years, urologists and patients have dealt with the effects of the BCG shortage. A new expanded access program (EAP) authorized by the FDA, in which ImmunityBio is …
ImmunityBio Announces First Dosing of Recombinant BCG (rBCG) …
2025年3月13日 · The Serum Institute of India, ImmunityBio’s collaboration partner, is the world’s largest manufacturer of vaccines by volume. In bladder cancer clinical trials in Europe, the …
Suzanne B. Merrill, MD, FACS, on EAP program for recombinant BCG
4 天之前 · An expanded access program (EAP) to provide recombinant BCG (rBCG) in the US was recently authorized by the FDA. 1 For the EAP, ImmunityBio has partnered with the …
FDA Allows Use of Recombinant BCG Through Expanded Access …
2025年2月21日 · Providers who are unable to source TICE BCG will now be able to access rBCG through the expanded access program. The rBCG product, which was developed by the …