Representational image only. | Photo Credit: The Hindu Biocon Limited on October 18 said the U.S. health regulator has classified as ‘official action indicated’ for the manufacturing facility of group firm Biocon Sdn Bhd at Johor, Malaysia following an inspection. The OAI (Official Action Indicated) status may cause delay and/or withholding of pending product approvals … Read more
Bengaluru: Elon Musk‘s brain-implant company Neuralink on Thursday said it had received a green light from the US Food and Drug Administration (FDA) to kickstart its first-in-human clinical study, a critical milestone after earlier struggles to gain approval. On at least four occasions since 2019, Musk has predicted that his medical device company would begin … Read more
New Delhi: Homegrown MedTech solutions provider Xplore Health on Thursday announced that it received approval from the Indian Regulatory Authority CDSCO (Central Drug Standard Control Organisation) under the Health Ministry of India for its aspirational medical smartwatch “CardiacSense“. The approval came ahead of its commercial launch in collaboration with Israeli Medtech company CardiacSense Ltd. The … Read more
In a warning letter, the US Food and Drug Administration pointed out various lapses at the Halol plant which produces finished pharmaceutical products. | Photo Credit: Special Arrangement The U.S. health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of … Read more
March 21, 2022 — The FDA today announced its vaccines advisory committee will meet April 6 to discuss the future of COVID-19 booster doses and how to tell if a specific strain of the coronavirus needs its own vaccine. The independent experts on the Vaccines and Related Biological Products Advisory Committee will be joined by … Read more
Covaxin (BBVI52), which has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is an investigational vaccine candidate product in the US. Bharat Biotech on Saturday said its Covaxin will be evaluated as a COVID-19 vaccine candidate in the US. In a statement, Ocugen Inc, Bharat Biotech’s partner in … Read more
While the scientific studies didn’t find a clear winner, it showed that all the booster shots provided strong antibody response, regardless of the combination. (File/Reuters) The US Food and Drug Administration (FDA) recently approved a mix-and-match booster shot plan that allows the eligible adult population to choose from one of three vaccines — Moderna, Pfizer-BioNTech, … Read more
New Delhi: Drug firm Zydus Cadila on Monday said it has received final approval from the US health regulator to market Tofacitinib extended-release tablets, used to treat rheumatoid arthritis, in the American market. The company said it has received approval from the US Food and Drug Administration (USFDA) for the drug in 11 mg and … Read more
China has given conditional approval for a single dose COVID-19 vaccine, touted to be a rival to Johnson & Johnson’s one-jab shot cleared by the US drug regulator on Sunday. China’s first Ad5-nCoV COVID-19 vaccine was rolled out on Friday, the state-run Global Times reported on Sunday. Phase-I clinical trials of the vaccine started on … Read more
The White House coronavirus task force in its latest report said that the United States may have its own version of a more transmissible variant of Covid-19 that might be helping fuel the already aggressive spread of the virus. Reports sent by the task force to states dated to January 3 warned of the possibility … Read more