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<feedburner:origLink>https://insights.citeline.com/pink-sheet/podcasts/pink-sheet-podcast-peptide-compoundings-broader-implications-industry-opposes-crl-release-6LLLMROH35BBJISHSJFMTM7X4U/</feedburner:origLink><title><![CDATA[Pink Sheet Podcast: Peptide Compounding’s Broader Implications; Industry Opposes CRL Release]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972126929/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972126929/0/pink~Pink-Sheet-Podcast-Peptide-Compounding%e2%80%99s-Broader-Implications-Industry-Opposes-CRL-Release/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/podcasts/pink-sheet-podcast-peptide-compoundings-broader-implications-industry-opposes-crl-release-6LLLMROH35BBJISHSJFMTM7X4U/</guid><dc:creator><![CDATA[Derrick Gingery, Sue Sutter, Maaisha  Osman, Nielsen Hobbs]]></dc:creator><description><![CDATA[Pink Sheet reporter and editors discuss the potential changes to drug development that could result from the Health and Human Services Department’s order to allow compounding of unapproved peptides, as well as industry’s push to stop the US FDA from releasing complete response letters.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/1r_KkFWc2e0VjQQIGip_U0TRKTQ=/cloudfront-us-east-1.images.arcpublishing.com/norstella/PEOGXQSDHBC6ZKAUJVVXHLBLV4.png" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/1r_KkFWc2e0VjQQIGip_U0TRKTQ=/cloudfront-us-east-1.images.arcpublishing.com/norstella/PEOGXQSDHBC6ZKAUJVVXHLBLV4.png"/></a></div>
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</description><pubDate>Fri, 30 Oct 2026 16:56:04 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/1r_KkFWc2e0VjQQIGip_U0TRKTQ=/cloudfront-us-east-1.images.arcpublishing.com/norstella/PEOGXQSDHBC6ZKAUJVVXHLBLV4.png" type="image/png" height="675" width="1200"><media:description type="plain"><![CDATA[Will industry and the FDA reach a middle ground allowing the release of complete response letters?]]></media:description><media:credit role="author" scheme="urn:ebu"></media:credit></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/pink-sheet/product-reviews/eu-chmp/new-eu-filings-NBVQ7BXZUJCUZF6LDB46SA4R4A/</feedburner:origLink><title><![CDATA[New EU Filings]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972119006/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972119006/0/pink~New-EU-Filings/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/product-reviews/eu-chmp/new-eu-filings-NBVQ7BXZUJCUZF6LDB46SA4R4A/</guid><dc:creator><![CDATA[Neena Brizmohun]]></dc:creator><description><![CDATA[Varegacestat, Immunome's treatment for adults with desmoid tumors, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/qr4HqLM3X7pfzfb_UShZ54G3B6w=/cloudfront-us-east-1.images.arcpublishing.com/norstella/R2VDCMSQWVJTVG72SZJTX6TEA4.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/qr4HqLM3X7pfzfb_UShZ54G3B6w=/cloudfront-us-east-1.images.arcpublishing.com/norstella/R2VDCMSQWVJTVG72SZJTX6TEA4.jpg"/></a></div>
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</description><pubDate>Fri, 30 Oct 2026 12:25:48 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/qr4HqLM3X7pfzfb_UShZ54G3B6w=/cloudfront-us-east-1.images.arcpublishing.com/norstella/R2VDCMSQWVJTVG72SZJTX6TEA4.jpg" type="image/jpeg" height="675" width="1200"/></item>
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<feedburner:origLink>https://insights.citeline.com/pink-sheet/compliance/manufacturing/eu-opens-smoother-import-route-for-singapore-made-apis-3C2LXULDDZH6PAWCTD6Y657FPY/</feedburner:origLink><title><![CDATA[EU Opens Smoother Import Route For Singapore-Made APIs ]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972119360/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972119360/0/pink~EU-Opens-Smoother-Import-Route-For-SingaporeMade-APIs/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/compliance/manufacturing/eu-opens-smoother-import-route-for-singapore-made-apis-3C2LXULDDZH6PAWCTD6Y657FPY/</guid><dc:creator><![CDATA[Neena Brizmohun]]></dc:creator><description><![CDATA[Singapore has become the 10th country to secure EU recognition of its regulatory framework for active pharmaceutical substances, removing a key documentation requirement for API exports to the bloc.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/zm4G8EtVC5h_ZNtDC0cJk0eOXX8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/774DFZD3K5G4LEMWKJHEHQDXTU.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/zm4G8EtVC5h_ZNtDC0cJk0eOXX8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/774DFZD3K5G4LEMWKJHEHQDXTU.jpg"/></a></div>
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</description><pubDate>Fri, 30 Oct 2026 12:52:14 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/zm4G8EtVC5h_ZNtDC0cJk0eOXX8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/774DFZD3K5G4LEMWKJHEHQDXTU.jpg" type="image/jpeg" height="668" width="1000"><media:description type="plain"><![CDATA[The EU has added Singapore to its list of recognized third countries for importation of APIs]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/pink-sheet/drug-safety/us-fda-strips-boxed-label-warnings-from-three-menopause-hormone-patches-eyes-otc-move-RKGXTBTFDND6FIIKV5XYAJBMUI/</feedburner:origLink><title><![CDATA[US FDA Strips Boxed Label Warnings From Three Menopause Hormone Patches, Eyes OTC Move]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972132158/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972132158/0/pink~US-FDA-Strips-Boxed-Label-Warnings-From-Three-Menopause-Hormone-Patches-Eyes-OTC-Move/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/drug-safety/us-fda-strips-boxed-label-warnings-from-three-menopause-hormone-patches-eyes-otc-move-RKGXTBTFDND6FIIKV5XYAJBMUI/</guid><dc:creator><![CDATA[Sue Sutter]]></dc:creator><description><![CDATA[The agency removed boxed warnings on cardiovascular risk, breast cancer and probable dementia for three estradiol transdermal patches, bringing to nine the total number of menopausal hormone therapy products that had labeling changes under the agency's November directive.
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</description><pubDate>Fri, 30 Oct 2026 20:56:27 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/7apkRXMzD9PKAwzuCVs5hSNdsaY=/cloudfront-us-east-1.images.arcpublishing.com/norstella/4VW7DRQ735F3PNBMUXAASSR2HE.jpg" type="image/jpeg" height="667" width="1000"><media:description type="plain"><![CDATA[Some boxed warnings have been removed from labeling for menopause hormonal therapy patches.]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/pink-sheet/product-reviews/us-fdas-november-calendar-pairs-big-oncology-bets-with-potential-rare-disease-firsts-PY2UJ65W35GFTGCHZUB6B7M4B4/</feedburner:origLink><title><![CDATA[US FDA’s November Calendar Pairs Big Oncology Bets With Potential Rare Disease Firsts]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972130571/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972130571/0/pink~US-FDA%e2%80%99s-November-Calendar-Pairs-Big-Oncology-Bets-With-Potential-Rare-Disease-Firsts/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/product-reviews/us-fdas-november-calendar-pairs-big-oncology-bets-with-potential-rare-disease-firsts-PY2UJ65W35GFTGCHZUB6B7M4B4/</guid><dc:creator><![CDATA[Bridget Silverman]]></dc:creator><description><![CDATA[Summit’s ivonescimab and Roche’s giredestrant lead a 14-novel-agent lineup, where the FDA could reject nine and still beat last year’s approval count.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/t4lOA9rDu-nJCKLNk06w6iZ0u8I=/cloudfront-us-east-1.images.arcpublishing.com/norstella/PDZLI3NQIJGC3DOYQU2HJHEKPM.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/t4lOA9rDu-nJCKLNk06w6iZ0u8I=/cloudfront-us-east-1.images.arcpublishing.com/norstella/PDZLI3NQIJGC3DOYQU2HJHEKPM.jpg"/></a></div>
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</description><pubDate>Fri, 30 Oct 2026 20:07:00 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/t4lOA9rDu-nJCKLNk06w6iZ0u8I=/cloudfront-us-east-1.images.arcpublishing.com/norstella/PDZLI3NQIJGC3DOYQU2HJHEKPM.jpg" type="image/jpeg" height="3264" width="4896"><media:description type="plain"><![CDATA[The November FDA user fee goal dates include 14 novel agents.]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/pink-sheet/conferences/topra/faster-eu-trial-review-speed-will-mean-little-if-sponsors-cannot-keep-up-novartis-says-H5AQP6734ZFX5NNJRQZFLXNTOQ/</feedburner:origLink><title><![CDATA[Faster EU Trial Review Will Mean Little If Sponsors Cannot Keep Up, Novartis Says]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972122381/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972122381/0/pink~Faster-EU-Trial-Review-Will-Mean-Little-If-Sponsors-Cannot-Keep-Up-Novartis-Says/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/conferences/topra/faster-eu-trial-review-speed-will-mean-little-if-sponsors-cannot-keep-up-novartis-says-H5AQP6734ZFX5NNJRQZFLXNTOQ/</guid><dc:creator><![CDATA[Dean Rudge]]></dc:creator><description><![CDATA[Faster EU review of multinational clinical trial applications will deliver limited benefits unless sponsors also speed up site contracting and other start-up activities, a Novartis executive says based on the company’s experience in the FAST-EU pilot.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/ObXzoBev2ifWSlgp6k77z_aXXp4=/cloudfront-us-east-1.images.arcpublishing.com/norstella/QNOE5QI6TVNZ3BKAJKORC3FCIM.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/ObXzoBev2ifWSlgp6k77z_aXXp4=/cloudfront-us-east-1.images.arcpublishing.com/norstella/QNOE5QI6TVNZ3BKAJKORC3FCIM.jpg"/></a></div>
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</description><pubDate>Fri, 30 Oct 2026 13:53:43 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/ObXzoBev2ifWSlgp6k77z_aXXp4=/cloudfront-us-east-1.images.arcpublishing.com/norstella/QNOE5QI6TVNZ3BKAJKORC3FCIM.jpg" type="image/jpeg" height="675" width="1200"><media:description type="plain"><![CDATA[Souce: Shutterstock]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/adcomm-supports-us-fda-verdict-on-sydnexis-myopia-drug-finds-trial-and-literature-issues-VAR6CT4OPZCUTD3VZFWBMSKN6Q/</feedburner:origLink><title><![CDATA[AdComm Supports US FDA Verdict On Sydnexis’ Myopia Drug, Finds Trial And Literature Issues]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972136523/0/pink">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972136523/0/pink~AdComm-Supports-US-FDA-Verdict-On-Sydnexis%e2%80%99-Myopia-Drug-Finds-Trial-And-Literature-Issues/</link><guid isPermaLink="true">https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/adcomm-supports-us-fda-verdict-on-sydnexis-myopia-drug-finds-trial-and-literature-issues-VAR6CT4OPZCUTD3VZFWBMSKN6Q/</guid><dc:creator><![CDATA[Bridget Silverman]]></dc:creator><description><![CDATA[At an Oct. 30 meeting related to Sydnexis’ formal dispute of an FDA complete response letter, advisory committee members found weaknesses in the Phase III trial and the published literature supporting SYD-101.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/tRLlO9yB5xE074eWJEmf4MpEzBc=/cloudfront-us-east-1.images.arcpublishing.com/norstella/JVYEUDG6GFG2BFAAA2D6KXRSZU.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/tRLlO9yB5xE074eWJEmf4MpEzBc=/cloudfront-us-east-1.images.arcpublishing.com/norstella/JVYEUDG6GFG2BFAAA2D6KXRSZU.jpg"/></a></div>
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</description><pubDate>Sat, 31 Oct 2026 01:34:54 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/tRLlO9yB5xE074eWJEmf4MpEzBc=/cloudfront-us-east-1.images.arcpublishing.com/norstella/JVYEUDG6GFG2BFAAA2D6KXRSZU.jpg" type="image/jpeg" height="4160" width="6240"><media:description type="plain"><![CDATA[Sydnexis wants to bring the first branded low-dose atropine eyedrops to US children with myopia.]]></media:description></media:content></item>
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