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- Read more about FDA approves device to help increase access to more lungs for transplant
The U.S. Food and Drug Administration approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought to be unacceptable for transplant. The device allows the transplant team to perform a more careful assessment of lung function to get a better sense of how the organs are working when they are perfused with a solution outside the body to better determine whether the lungs can then be viable for transplant.
- Read more about EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo
that Lartruvo (olaratumab) with doxorubicin does not prolong the lives of patients with soft tissue cancer more than doxorubicin alone. The Agency is therefore recommending that the marketing authorisation of the medicine be revoked.
- Read more about World's first Malaria Vaccine distribution started
WHO welcomes the Government of Malawi’s launch of the world’s first malaria vaccine in a landmark pilot programme. The country is the first of three in Africa in which the vaccine, known as RTS,S, will be made available to children up to 2 years of age; Ghana and Kenya will introduce the vaccine in the coming weeks.
- Read more about Scientists translate brain signals into speech sounds
Scientists used brain signals recorded from epilepsy patients to program a computer to mimic natural speech — an advancement that could one day have a profound effect on the ability of certain patients to communicate. The study was supported by the National Institutes of Health’s Brain Research through Advancing Innovative Technologies (BRAIN) Initiative.
- Read more about NIH to rocket 3-D tissue chips into space to study disease in microgravity
Miniaturized models of the lung and bone marrow, kidney, blood-brain barrier and bone cartilage will blast off on April 30 to the International Space Station National Lab (ISS National Lab) on a Falcon 9 rocket from Cape Canaveral, Florida.
- Read more about Indian have poor access to anticancer drugs : Study
Limited access to essential medicines for treating chronic diseases is a major challenge in low and middle-income countries. Although India is the largest manufacturer of generic medicines, there is a paucity of information on availability, price and affordability of essential anti-cancer medicines used for treating childhood cancers.
- Read more about Biocon grown by 64% in net profit at Rs 213.7 cr during fourth quarter
Biocon Ltd announced its consolidated financial results for the fourth quarter and fiscal year ended March 31st, 2019. Biocon Biologics revenue nearly doubled, led by biosimilars portfolio performance in developed and emerging markets. Branded Formulations India business reported a strong double digit growth which was offset by a decline in UAE. Generic Formulations business grew multi-fold off a low base, reflecting our focus on vertical integration in the Small Molecules business. Research Services subsidiary Syngene crossed the Rs 500 Crore Revenue milestone with a Net Profit milestone of Rs 100 Crore in Q4 on a standalone basis.
- Read more about Alembic Pharmaceuticals receives USFDA Approval for Teriflunomide Tablets 7 mg and 14 mg
Alembic Pharmaceuticals Limited announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Teriflunomide Tablets, 7 mg and 14 mg.
- Read more about FDA permits marketing of first medical device for treatment of ADHD
The U.S. Food and Drug Administration permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication and is the first non-drug treatment for ADHD granted marketing authorization by the FDA.
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- Read more about FDA approves first generic naloxone nasal spray to treat opioid overdose
The U.S. Food and Drug Administration granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. The agency is also planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an over-the-counter naloxone product.