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Home » Topics » Regulatory

Regulatory
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FDA vaccine illustration

US FDA preparing for a future of COVID-19 boosters

March 21, 2022
By Mari Serebrov
"Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against and treat,” the FDA’s Peter Marks said in announcing an April 6 virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
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Opdualag

This is just the beginning, says LAG-3 discoverer as BMS grabs first-in-class approval

March 21, 2022
By Jennifer Boggs and Richard Staines
Bristol Myers Squibb Co.’s relatlimab will hit the market as the first U.S. FDA-approved LAG-3 inhibitor, cleared by the agency for use in a fixed-dose combination with Opdivo (nivolumab) to treat adult and pediatric patients with unresectable or metastatic melanoma. The approval, a day ahead of the March 19 FDA target date, adds another type of immune checkpoint inhibitor to the oncology arsenal, which already includes drugs targeting PD-1/PD-L1 and CTLA4.
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Regulatory actions for March 21, 2022

March 21, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astrazeneca, Cstone, Kiora, Moderna, Sobi.
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Marinus wins first nod as FDA clears Ztalmy in rare CDKL5 deficiency disorder

March 18, 2022
By Jennifer Boggs and Lee Landenberger
Marinus Pharmaceuticals Inc.’s GABAA receptor agonist Ztalmy (ganaxolone), has won U.S. FDA approval for treating seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder.
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Health professional touching screen, digital/medical icons
HIMSS 2022

Digital innovation highlighted as companies are called to ‘reimagine’ health

March 18, 2022
By Catherine Longworth
At this year’s Healthcare Information and Management Systems Society (HIMSS) 2022 conference in Orlando, Fla., digital health companies across the sector gathered to showcase new products and services. HIMSS CEO Hal Wolf urged the industry to focus on global health equity and a 2022 survey of health care leaders highlighted the elements of digital transformation that are causing the biggest buzz.
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Chinese flag on flagpole

Sihuan awarded medical device registration for skin repair products by NMPA

March 18, 2022
By Doris Yu
China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform Beijing Meiyan Kongjian Biology Medicine Co. Ltd. The certification is for three scar repair products, four medical dressing and patch products, as well as three skin repair products.
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Regulatory actions for March 18, 2022

March 18, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amolyt, Aquestive, Bioheng, Heron, Inflarx, Moderna, TC, Tetra.
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Man sleeping with CPAP machine

Philips recall woes continue across the globe

March 17, 2022
By Bernard Banga
Royal Philips NV has been handed a health care policy order requiring it to recall and replace 277,500 defective respiratory therapy devices in France within four months. Twelve ranges of respiratory device for patients who depend on mechanical breathing assistance as well as continuous positive airway pressure devices used to treat sleep apnea, have been affected by a design issue.
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Regulatory actions for March 17, 2022

March 17, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adagene, Aim Immunotech, Biontech, Brii, Iovance, Kaléo, Ossium Health, Pfizer, Shionogi, Sonnet, The AIDS Clinical Trials Group.
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Regulatory actions for March 17, 2022

March 17, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medicine, Minute Molecular Diagnostics.
Read More
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