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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 …
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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.
— …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …