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    • Serono FDA

Serono FDA Newsletter
  • FDA Approved Drug Products Approval List March 2024 30 Mar 2024 10:39 GMT

    Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status 03/01/2024 CORTIFOAMNDA   #017351 SUPPL-41 HYDROCORTISONE ACETATE MYLAN SPECIALITY LP Labeling Approval 03/01/2024 TRANSDERM SCOPNDA …

  • Blockbuster BeiGene Cancer Drug Adds Another FDA Approval 10 Mar 2024 13:09 GMT

    … and Aimax Therapeutics received FDA approval for a new … progression-free survival. —EMD Serono, the healthcare business of … discuss the FDA letter. —Allecra Therapeutics received FDA approval for … Velsipity follows the drug’s FDA approval last October. — …

  • EMD Serono Presents New MAVENCLAD® Data Supporting Cognitive Function Benefits 29 Feb 2024 13:14 GMT

    … S. Food and Drug Administration (FDA) on March 29, 2019, is … 5563 or FDA at 1-800-FDA-1088 or www.fda.gov… the science. About EMD Serono, Inc. EMD Serono - the healthcare business … MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics …

  • FDA Roundup: February 16, 2024 17 Feb 2024 06:05 GMT

    … the FDA converted approval of tepotinib (Tepmetko, EMD Serono, Inc.) … . In 2021, the FDA granted Breakthrough Device designation … patients. On Tuesday, the FDA approved irinotecan liposome (Onivyde … This marketing clearance reflects FDA’s ongoing commitment to …

  • FDA expands label for Novartis and Roche's blockbuster, converts EMD Serono's NSCLC drug to full approval 16 Feb 2024 21:08 GMT

    The FDA on Fri­day signed off on … to full ap­proval for EMD Serono’s non-small cell lung …

  • FDA Roundup: February 16, 2024 16 Feb 2024 20:43 GMT

    … the FDA converted approval of tepotinib (Tepmetko, EMD Serono, Inc.) … . In 2021, the FDA granted Breakthrough Device designation … patients. On Tuesday, the FDA approved irinotecan liposome (Onivyde … This marketing clearance reflects FDA’s ongoing commitment to …

  • FDA Grants Full Approval to Tepmetko for Metastatic NSCLC Subtype 16 Feb 2024 19:32 GMT

    … and MET amplifications. The FDA previously granted accelerated approval to … resources-information-approved-drugs/fda-grants-accelerated-approval-tepotinib-metastatic … 3. Tepmetko. Prescribing information. EMD Serono; 2024. Accessed February 16, 2024 …

  • FDA approves tepotinib for metastatic non-small cell lung cancer 16 Feb 2024 01:56 GMT

    … to tepotinib (Tepmetko, EMD Serono, Inc.) for adult patients … applicant to facilitate the FDA’s assessment. This application … and orphan drug designation. FDA expedited programs are described in … 402-0004 or email OncProjectFacilitate@fda.hhs.gov. Follow the …

  • FDA Approves Pfizer COVID-19 Vaccine for Those Ages 16 Years and Older 13 Feb 2024 21:46 GMT

    … certain immunocompromised individuals. “The FDA’s approval of this … and manufacturing quality the FDA requires of an approved product … Janet Woodcock, MD, acting FDA commissioner, said in a … only cladribine (Mavenclad; EMD Serono) did not impair humoral …

  • FDA grants breakthrough therapy designation to opioid with ‘overdose protection’ 29 Jan 2024 13:19 GMT

    … a protease inhibitor. The FDA has granted breakthrough therapy … in the release. The FDA has granted breakthrough therapy designation … E. Lane, MD The FDA has assigned breakthrough therapy … reports consulting for EMD-Merck Serono, Novartis, Pfizer/Lilly …

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