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FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics | The Manila Times

Recommendations aim to help provide clearer safety information for use during pregnancy

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https://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-genome-editing-safety-standards-advance-gene-therapy-development

FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development | FDA

https://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-genome-editing-safety-standards-advance-gene-therapy-development
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The Power of Community to Improve Asthma and Allergy Health | The Manila Times

https://www.manilatimes.net/2026/04/30/tmt-newswire/globenewswire/the-power-of-community-to-improve-asthma-and-allergy-health/2332600
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Webinar to Spotlight SCR and DEF Technologies and Address EPA Guidance and Current Industry Issues | The Manila Times

https://www.manilatimes.net/2026/04/08/tmt-newswire/globenewswire/webinar-to-spotlight-scr-and-def-technologies-and-address-epa-guidance-and-current-industry-issues/2315801
https://www.manilatimes.net/2026/02/23/tmt-newswire/globenewswire/ultragenyx-announces-us-fda-acceptance-and-priority-review-of-the-biologics-license-application-bla-for-dtx401-aav-gene-therapy-for-glycogen-storage-disease-type-ia-gsdia/2283059

Ultragenyx Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application (BLA) for DTX401 AAV Gene Therapy for Glycogen Storage Disease Type Ia (GSDIa) | The Manila Times

https://www.manilatimes.net/2026/02/23/tmt-newswire/globenewswire/ultragenyx-announces-us-fda-acceptance-and-priority-review-of-the-biologics-license-application-bla-for-dtx401-aav-gene-therapy-for-glycogen-storage-disease-type-ia-gsdia/2283059
https://www.manilatimes.net/2026/04/11/tmt-newswire/globenewswire/replimune-receives-complete-response-letter-from-the-fda-for-rp1-biologics-license-application-for-the-treatment-of-advanced-melanoma/2318307

Replimune Receives Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma | The Manila Times

https://www.manilatimes.net/2026/04/11/tmt-newswire/globenewswire/replimune-receives-complete-response-letter-from-the-fda-for-rp1-biologics-license-application-for-the-treatment-of-advanced-melanoma/2318307