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USFDA grants VAI classification to Dr Reddy's R&D centre

Dr Reddy's Laboratories announced that its Hyderabad-based R&D centre has received Voluntary Action Indicated (VAI) classification from the US FDA after an inspection. This classification indicates that objectionable conditions or practices were found, but no further administrative or regulatory action is required.

Hyderabad , Andhra-pradesh , India , Drug-administration , Product-development-organisation-in-bachupally , Voluntary-action-indicated , Good-manufacturing-practice , Usfda , Dr-reddys-laboratories , R-ampd-centre , Us-health-regulator

usfda: Strides Pharma arm gets USFDA nod for generic Mycophenolate Mofetil oral suspension

Strides Pharma Science Ltd on Wednesday said its wholly-owned arm, Strides Pharma Global Pte. Ltd, Singapore, has received approval from the US health regulator for generic Mycophenolate Mofetil for oral suspension indicated in organ transplant patients to avoid rejection. The approval granted by the US Food & Drug Administration (USFDA) is for Mycophenolate Mofetil for oral suspension of strength 200 mg/ml, Strides Pharma Science said in a regulatory filing.

Drug-administration , Usfda , Rld , Cellcept , Llc , Pharma-science , Oral-suspension , Strides-pharma-global , Us-health-regulator , Us-food-amp-drug-administration , Singapore

Zydus Gets US Regulator's Approval To Market Generic Drug For Myxedema Coma

Zydus Lifesciences today said it has received approval from the US health regulator to market a generic product which is used to treat myxedema coma.

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US Health Regulator Lists 378 Hand Sanitisers Consumers Should Not Use

Amid rising COVID-19 cases in China, the US Food and Drug Administration (FDA) released a list of hand sanitisers it recommends avoiding.

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LASIK Patients Should Be Warned of Risks Before Eye Procedure, Says US Health Regulator

LASIK - Laser-Assisted In Situ Keratomileusis - is the most commonly performed laser refractive surgery used to correct common vision problems. However, the surgery is now under the lens of the US Food and Drug Administration (FDA).

Us-health-regulator , Drug-administration , Should-be-warned , Risks-before-eye-procedure , Assisted-in-situ-keratomileusis , Fox-news , Video-of-the , Lasik , Eye-surgery , Us-fda , Lasik-side-effects

Top 10 stocks for today

Here are the top 10 stocks with major news in them and the potential to move the markets.

Mumbai , Maharashtra , India , Singapore , Sun-pharma , Bajaj-finserv , Axis-bank , Macrotech-developers , Mahindra , Visteon-corporation , Drug-administration , Indian-energy-exchange

Что случилось этой ночью: четверг, 23 сентября

Что случилось этой ночью: четверг, 23 сентября
interfax.ru - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from interfax.ru Daily Mail and Mail on Sunday newspapers.

Moscow , Moskva , Russia , Kazakhstan , United-states , Poland , Algeria , Morocco , Russians , Algerian , Moroccan , American

НГ: Счет не по игре - Как «Тобол» одержал вторую победу над «Кызыл-Жаром» и вышел в полуфинал Кубка РК

НГ: Счет не по игре - Как «Тобол» одержал вторую победу над «Кызыл-Жаром» и вышел в полуфинал Кубка РК
ng.kz - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from ng.kz Daily Mail and Mail on Sunday newspapers.

Moscow , Moskva , Russia , Georgia , United-states , Kazakhstan , Algeria , Morocco , Portugal , Poland , Ukraine

Zydus Cadila gets tentative USFDA nod to market lung cancer drug

Zydus Cadila gets tentative USFDA nod to market lung cancer drug
PTI
New Delhi |
Updated on
June 03, 2021
The drug to be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad
Drug firm Zydus Cadila on Thursday said it has received tentative approval from the US health regulator to market Osimertinib tablets, used to treat lung cancer.
The company has received tentative approval from the US Food and Drug Administration (USFDA) to market Osimertinib tablets in the strengths of 40 mg and 80 mg, Zydus Cadila, part of the Cadila Healthcare group, said in a regulatory filing.
Osimertinib is used to treat lung cancer. Osimertinib works by slowing or stopping the growth of cancer cells.

Ahmedabad , Gujarat , India , Zydus-cadila , Drug-administration , Cadila-healthcare , Tentative-approval , Us-health-regulator , Osimertinib-tablets , Lung-cancer , Abbreviated-new-drug-applications , அஹமதாபாத்

Natco Pharma gets American drug regulator's nod for generic cancer treatment drug

Natco, along with its marketing partner Arrow International previously settled the Paragraph IV litigation related to the product with Celgene, now part of Bristol-Myers Squibb, who sells the product under the brand name 'Revlimid', it added.

Zortress-everolimus , Bristol-myers-squibb , Natco-pharma , Drug-administration , Breckenridge-pharmaceutical-inc , Arrow-international , Pharmaceutical-inc , Us-food-and-drug-administration , Usfda , Natco , Anda , Us-health-regulator