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US FDA mulls approving second COVID booster shot - Express Pharma
Nov 22, 2022 - The planning is still in early stages, though
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US FDA approves NuVasive Pulse platform for spine surgeries
Feb 10, 2023 - NuVasive has announced its receipt of US FDA 510(k) approval as well as the commercial launch of its Pulse platform for spine surgeries.
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Piramal Pharma has confirmed that the US Food and Drug Administration (FDA) has completed its inspection of the Lexington facility. The issuance of an EIR...
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Cipla stocks gained by 5% after FDA inspection with no data integrity and repeat observations at its indore facilitated formulation unit.
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Japan's Daiichi Sankyo gets US FDA nod for blood cancer treatment, ETHealthworld
Daiichi: The drug, which is already approved in Japan has faced a long path to the U.S. market, with the Food and Drug Administration (FDA) declining to...
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Mar 10, 2004 - Tokyo-based Chisso Corporation has announced that its natural food additive Polylysine has recently acquired certification by the US Food and Drug...
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On February 9, 2023, Mesoblast Limited (ASX: MSB) announced that their prestigious product, Rexlemestrocel-L, has earned the Regenerative Medicine Advanced...
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Nov 6, 2025 - Lords Mark Industries Ltd. has officially obtained registration from the US Food and Drug Administration (US FDA) for its comprehensive range of surgical...
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Lupin's Aurangabad-based facility gets two observations from US FDA
Lupin's Aurangabad-based facility gets two observations from US FDA
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https://pakistanlivenews.com/us-fda-approves-drug-to-treat-genetic-disorder/
US FDA Approves Drug To Treat Genetic Disorder - Pakistan Live News
Mar 25, 2023 - The US Food and Drug Administration (FDA) on Friday approved Pharming Group's drug to treat a rare genetic disorder that leads to a weakened immune system,
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Yisheng Biopharma's PIKA rabies vaccine receives US FDA orphan drug designation
Yisheng Biopharma's PIKA rabies vaccine receives US FDA orphan drug designation
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https://www.bioworld.com/articles/729762-us-fda-clears-four-nmes-including-those-for-dermatitis-achondroplasia?v=preview
US FDA clears four NMEs, including those for dermatitis, achondroplasia | BioWorld
Drug approvals by the U.S. FDA totaled 26 in the first two months of 2026, with eight approvals in January and 18 in February. Compared with 2025, when...
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https://www.easternmirrornagaland.com/lupin-receives-us-fda-approval-for-its-generic-cancer-drug
Lupin receives US FDA approval for its generic cancer drug
Lupin announced that the US FDA has approved its abbreviated new drug application for Lenalidomide capsules
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US FDA Procures DILIsym Software License Package - Simulations Plus
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US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults | MarketScreener India
Jun 13, 2025 - The U.S. Food and Drug Administration on Thursday expanded the use of Moderna's respiratory syncytial virus vaccine to a lower group of adults aged 18 to 59...
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Lupin Gets Tentative Approval from US FDA for RLD Sutab - Drug Discovery & Development
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Aurobindo Pharma Arm Gets One Observation In US FDA Inspection Of Tirupati Plant - Inventiva
Sep 20, 2023 - Aurobindo Pharma's subsidiary, APL Healthcare Limited, has disclosed that it received a 'Form 483' notification from the US Food and Drug Administration (FDA)
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The US FDA issues best practices for communicating cybersecurity vulnerabilities to patient |...
Feb 26, 2022 - The U.S. Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) published best practices for communicating cybersecurity
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Changes ahead as the US FDA proposes longer national drug codes
The national drug code (NDC) is a unique number used by the US Food and Drug Administration (FDA) to identify and report drugs
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KK Care Hospital Collaborates With ORTHOReNEW To Launch US FDA-Approved Regenerative Medicine -...
Aug 12, 2025 - KK Care Hospital operates as a multispeciality healthcare provider with two units in Charholi and Alandi, Pune.
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https://d2233.cms.socastsrm.com/2026/03/18/us-fda-pushes-for-new-methods-to-replace-animal-testing-in-early-drug-studies/
US FDA pushes for new methods to replace animal testing in early drug studies | MWC...
March 18 (Reuters) - The U.S. Food and Drug Administration on Wednesday issued a draft guidance to help companies reduce animal studies of experimental drugs...
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US FDA Proposes Revising Regulations for Determining When an Food Contact Notification is No Longer...
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Patient access to miltefosine in developing countries not secure despite award of US FDA PRV sold...
Jul 13, 2020 - DNDi and MSF urge Knight Therapeutics, Paladin, and Endo to commit to key drug access requirements for treatment of leishmaniasis worldwide. Knight...
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https://community.sitedata.org/groups/profile/422286/us-fda-expands-use-of-regeneronaposs-cholesterol-drug-in-young-children
US FDA Expands Use Of Regeneron's Cholesterol Drug In Young Children : SiteData Community
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Commentary on: US FDA Patient Decision Checklist for Breast Implants: Results of a Survey to...
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https://globalgrowthforum.com/nureca-limiteds-manufacturing-subsidiary-secures-us-fda-registration/
Nureca Limited's Manufacturing Subsidiary Secures US FDA Registration | GlobalGrowthForum
Apr 15, 2025 - Nureca Technologies Private Limited, the manufacturing subsidiary of Nureca Limited, has successfully completed its annual registration with the United States...
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https://brobible.com/culture/article/nationwide-shortage-adderall/
There Is Officially A Nationwide Shortage Of Adderall, Says The US FDA
Oct 14, 2022 - The FDA officially announced there is a shortage of Adderall, almost two months after pharmacists warned it was happening.
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Arjo receives 510(k) clearance from US FDA for WoundExpress | Arjo
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Transasia Bio-Medicals receives US FDA registration for in-vitro diagnostic instruments...
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Lupin's Pune-based biotech facility gets 5 observations from US FDA | Capital Market News -...
Lupin said that the U.S. FDA has completed a pre-approval inspection of the company's biotech facility located in Pune, India.
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Novavax's NuvaxovidReceives the US FDA Approval for Active Immunization against COVID-19 -...
May 20, 2025 - The US FDA has approved Nuvaxovid for active immunization against COVID-19, triggering a $175M milestone payment
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Erowid Kava Vault : US FDA Warns that Kava may be a Liver Load
The FDA issued a press release, following several other governments, that kava may be dangerous for people with liver disease.
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US FDA centers to deploy AI internally, following experimental run | The Star
May 9, 2025 - (Reuters) - The U.S. Food and Drug Administration said on Thursday all its centers will deploy artificial intelligence internally immediately, with full...
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BUZZ-Australia's Telix rises as US FDA accepts Pixclara drug application; Citi sees first revenue...
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https://www.sciencetimes.com/articles/33409/20210913/what-booster-shots-fda-set-discuss-pfizers-application-covid-19.htm
What Are Booster Shots? US FDA Set to Discuss Pfizer's Application for a COVID-19 Vaccine Third Dose
Sep 13, 2021 - Pfizer and Moderna were given authorization last month to give booster shots for those immunocompromised individuals, but the US health regulators are also now...
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US FDA and EMA accept Omeros regulatory applications for eye drug for review - Clinical Trials Arena
Oct 2, 2013 - Omeros Corporation (OMER) announced that its new drug application (NDA) for OMS302, an ophthalmology product, has been accepted for filing by the FDA and its...
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US FDA flags shortage of neurosurgical pads and sponges, expects disruption through 2026
May 6, 2026 - National News - May 6 (Reuters) - The U.S. Food and Drug Administration on Wednesday acknowledged ongoing supply disruptions of certain sterile pads, sponges...
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https://www.foxbusiness.com/healthcare/us-fda-approves-gilead-covid-drug-young-children
US FDA approves Gilead's COVID-19 drug for young children | Fox Business
The FDA has granted full approval to Gilead's remdesivir COVID-19 treatment for children 28 days and older.
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