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Inside the FDA’s New Voucher Program: First 9 Picks Target Diabetes to Vaping
23 Oct 2025 01:36 GMT
… increased interaction with FDA scientists during development … Alfa (Pergoveris)
Company: EMD Serono (Merck KGaA)
Indication: … fda-awards-first-ever-national-priority-vouchers-nine-sponsors
2. EMD Serono … . News release. EMD Serono. Published October 16, …
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<![CDATA[Inside the FDA’s New Voucher Program: First 9 Picks Target Diabetes to Vaping]]>
23 Oct 2025 00:52 GMT
… , and medication affordability.
The FDA described the initiative as a … along with increased interaction with FDA scientists during development and review … + Lutropin Alfa (Pergoveris)
Company: EMD Serono (Merck KGaA)
Indication: Infertility
Background …
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Trump Announces Lower-Cost Fertility Drug Deal With EMD Serono
20 Oct 2025 14:39 GMT
… that Boston-based drugmaker EMD Serono will lower the price … cycles to get pregnant.
EMD Serono’s medications, which also include … S. Food and Drug Administration (FDA) also plan to work together … expedite approval of an EMD Serono fertility drug used in Europe …
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Infertility treatment heads first drugs on FDA’s new priority review scheme
20 Oct 2025 11:46 GMT
… Canadian healthcare business EMD Serono. Gonal-f generated global … for specific diseases.
The FDA selected cytisinicline for nicotine … undertake enhanced feedback with FDA staff during development and … the American people,” said FDA commissioner Marty Makary.
…
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Medication madness, increasing involvement of private equity — why IVF costs so much, and how it may get worse
23 Oct 2025 11:34 GMT
… major fertility drug manufacturer EMD Serono, which has a US headquarters … said. “It’s actually the FDA that makes it very difficult … what kind of data the FDA will require, but the approval … not strictly enforced, and the FDA permits some individuals to import …
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Trump’s approach to lowering drug costs is raising questions
22 Oct 2025 23:25 GMT
… for tariff relief and expedited FDA review of another drug. … expedited review of drugs.
EMD Serono, which entered a deal … received one of the FDA’s inaugural National Priority Review … available in European markets.
FDA Commissioner Marty Makary earlier this …
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Trump announces lower prices for fertility medications
21 Oct 2025 13:17 GMT
… he announced that EMD Serono will lower the cost … IVF more affordable.
EMD Serono is a leading biopharmaceutical … . Additionally, EMD Serono is pursuing expedited FDA approval for Pergoveris®, … By partnering with EMD Serono to offer IVF medications …
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SpringWorks Therapeutics Announces Publication of Long-Term Efficacy and Safety Data from the Phase 3 DeFi Trial of OGSIVEO® (nirogacestat) in Adults with Desmoid Tumors in the Journal of Clinical Oncology
21 Oct 2025 06:00 GMT
… require systemic treatment. The FDA and the EMA have granted … 7989) or FDA at 1-800-FDA-1088 or www.fda.gov… commercializing the first and only FDA and EC approved medicine for … MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics …
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SpringWorks Therapeutics Announces Publication of Long-Term Efficacy and Safety Data from the Phase 3 DeFi Trial of OGSIVEO® (nirogacestat) in Adults with Desmoid Tumors in the Journal of Clinical Oncology
21 Oct 2025 06:00 GMT
… who require systemic treatment. The FDA and the EMA have granted … 7989) or FDA at 1-800-FDA-1088 or www.fda.gov… commercializing the first and only FDA and EC approved medicine for … MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics …
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Health Care Week in Review | OMB Initiates Significant Layoffs as Shutdown Continues; CMS Issues Updated Guidance to Temporarily Hold Claims Related to Expired Payment Provisions
20 Oct 2025 22:04 GMT
… Food and Drug Administration (FDA) released guidance entitled, Technical … On October 15, 2025, FDA released guidance entitled, Dual … .
December 10, 2025: FDA announced a workshop entitled, … its products. Additionally, EMD Serono’s pharmaceutical products and …