Representational image of Aurobindo Pharma’s Unit IX in Andhra Pradesh | Photo Credit: A. Roy Chowdhury The U.S. Food and Drug Administration (U.S. FDA) has classified a warehouse of Aurobindo Pharma subsidiary in New Jersey, U.S. as Official Action Indicated (OAI) after an inspection it conducted. Such a classification means regulatory and/or administrative actions are … Read more
Pune: DeepTek.ai’s AI-powered radiology workflow management solution, Augmento has received 510(k) clearance from the US Food and Drug Administration (FDA) for clinical use. The Indian Radiological and Imaging Association has released a report indicating a critical shortage of radiologists in the country. The ratio of radiologists to population is only one per 100,000 people, significantly … Read more
Bengaluru: Dozee announced its proprietary contactless vital signs (VS) measurement technology has received US FDA 510(k) clearance. According to nursing and midwifery professional organisations, India falls short of the WHO recommended rate of three nurses per 1,000 population and needs 4.3 million more nurses by 2024 to meet the WHO norms. Dozee aims to bridge … Read more
The U.S. Food and Drug Administration on Thursday authorized booster shots of the COVID-19 vaccine from Inc and BioNTech SE those aged 16 and 17, as public health officials have urged Americans to get the additional shots on concerns about the new Omicron variant of the virus. The emergency use authorization (EUA) will allow 16- … 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
Evrysdi® was first approved by the US FDA in August 2020 and is today available in India within 11 months of the US approval. Roche today announced the launch of Evrysdi® (risdiplam), the first and only approved treatment in India for Spinal Muscular Atrophy (SMA) patients. Evrysdi® (risdiplam) is the first and only oral treatment … Read more
Israel’s move to roll out booster shots comes amid reports of rising breakthrough infections. (Representational image: IE) Israel has recently started inoculating the country’s elderly residents with compromised immunity with a third dose of Pfizer-BioNTech’s Covid-19 vaccine. However, after meeting with Pfizer’s chief scientific officer on Monday, officials in the United States said more data … Read more
In the March quarter, Solara’s sales grew almost 50 per cent year-on-year to Rs 444 crore and net profit stood at Rs 56.6 crore, up 218 per cent. Synopsis The Mumbai-based reclusive investor held nearly 4 per cent stake in Sequent Scientific till March 2018 and about 2.07 per cent in Strides Pharma till September … Read more
The trend is to become self-reliant in API space and minimise dependency on China. Healthcare in India is vast, complex and full of paradoxes, but still one of the fastest-growing areas. It has undergone huge positive developments in terms of technology, medicines, R&D, or attracting Indian and international investors’ attention. The minds behind the healthcare … Read more
“Our emergency use authorization is not the same as a full approval,” Hahn said. (Courtesy: Reuters/File Photo) The head of the U.S. Food and Drug Administration (FDA) is willing to fast-track a COVID-19 vaccine as quickly as possible, the Financial Times reported him as saying in an interview published on Sunday. Dr. Stephen Hahn, the … Read more