Approvals

Government shutdown threatens biosimilar approvals, patent litigation

[ad_1] As the ongoing partial government shutdown continues in the United States, the FDA has approximately 5 weeks until drug user fees completely dry up, jeopardizing the review process for...

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Veristat Supports 12% of all FDA NME Approvals in 2018, a Record-Setting Year for FDA Approvals

[ad_1] SOUTHBOROUGH, Mass.--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/clinicalresearch?src=hash" target="_blank"gt;#clinicalresearchlt;/agt;--Veristat Supports 12% of all FDA NME Approvals in 2018, a Record-Setting Year for FDA Approvals Source link [ad_2]

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Global Intracranial Pressure Monitoring Devices Market 2019-2023| Increase in Regulatory Approvals for Products Impacting Market Growth| Technavio

[ad_1] LONDON--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/HealthCareEquipment?src=hash" target="_blank"gt;#HealthCareEquipmentlt;/agt;--The global intracranial pressure monitoring devices market 2019-2023 is expected to post a CAGR of close to 7%, according to Technavio. Source link [ad_2]

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Global Traumatic Brain Injury Therapeutics Market 2019-2023| Array of New Drug Approvals to Boost Growth| Technavio

[ad_1] LONDON--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/BrainInjuryTherapeutics?src=hash" target="_blank"gt;#BrainInjuryTherapeuticslt;/agt;--Technavio analysts forecast the global traumatic brain injury therapeutics market to grow at a CAGR of close to 5% during the period, 2019-2023. Source link [ad_2]

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The Future of Fatty Liver: From Education to Anticipated Approvals

[ad_1] The increasing prevalence of nonalcoholic fatty liver disease and its progressive form, nonalcoholic steatohepatitis, presents a significant need for therapeutic options. While no specific therapy or medication has yet...

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FDA Framework Signals Openness to Real-World Evidence for Drug Approvals

[ad_1] The agency says it will take a much more welcoming approach to the use of real-world data and real-world evidence in decision making regarding the approval of new drugs...

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Specialty Is Still A Big Player In Rx Approvals

[ad_1] Specialty medications dominated the drug approvals landscape in 2018—a repeat performance from last year, when a record 36 specialty drugs passed the FDA’s muster. As this issue of Pharmacy...

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FDA to Update Medical Device Approvals Process

[ad_1] Revised process will ensure new medical devices meet safety and effectiveness standards Source link [ad_1]

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FDA plans ‘generational’ overhaul of medical device approvals to make way for new technology

[ad_1] FDA plans ‘generational’ overhaul of medical device approvals to make way for new technology Source link [ad_2]

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STAT Plus: Pharmalittle: Bayer to overhaul R&D and cut jobs; FDA on pace for record number of generic approvals

Good morning, everyone, and how are you today? We are doing just fine, thank you, despite the changes brought by the end of the vacation season. Our shortest person is...

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How to Use Tentative Drug Approvals to Anticipate Generic Entry

Which Company Will be the First to Launch a Generic Drug? There are many reasons to find out which companies will be first to launch generic drugs. Payers need to…...

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DarioHealth attributes Q2 growth to new approvals, US launches, service offerings

The second quarter of 2018 was a strong one for the rapidly expanding DarioHealth. Touting 70 percent year-over-year revenue growth and a continued decline in its cash burn rate, CEO...

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8 recent reports on grants, approvals in clinical liver research

The FDA recently approved a thrombocytopenia therapy for adults with chronic liver disease and a combination therapy for advanced metastatic hepatocellular carcinoma. Along with these advancements, multiple societies have recently...

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The FDA Has the Authority to Explain Drug Application Rejections or Approvals. They Should Use It.

The FDA has the ability within its governing laws to reveal to the public the reasons for its decisions to reject or approve drugs. Source link

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