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https://www.jnj.com/media-center/press-releases/us-fda-grants-priority-review-to-bedaquiline-tmc207-for-multi-drug-resistant-tuberculosis-treatment U.S. FDA Grants Priority Review to Bedaquiline (TMC207) for Multi-Drug Resistant Tuberculosis... u s fda https://www.intertek.com/blog/2026/04-15-medical-device-cybersecurity-guidance/ U.S. FDA Reissues Medical Device Cybersecurity Guidance to Align with QMSR Apr 15, 2026 - The U.S. Food and Drug Administration (FDA) has once again reinforced a message that medical device manufacturers can no longer treat cybersecurity as a... u s fda medical device cybersecurity https://www.prnewswire.co.uk/news-releases/us-fda-acknowledges-receipt-of-resubmission-of-shires-new-drug-application-for-lifitegrast-for-dry-eye-disease-in-adults-567715091.html U.S. FDA Acknowledges Receipt of Resubmission of Shire's New Drug Application for Lifitegrast for... /PRNewswire/ -- - New FDA action date of July 22, 2016 - Lifitegrast has the potential to be the only product approved in the U.S. in the past decade... u s fda https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/moderna-receives-u.s.-fda-approval-for-covid-19-vaccine-mnexspike-1034131 Moderna Receives U.S. FDA Approval for COVID-19 Vaccine mNEXSPIKE mNEXSPIKE becomes Moderna's third FDA-approved product CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the ... u s fda covid 19 vaccine moderna receives https://www.takeda.com/newsroom/newsreleases/2020/takeda-announces-us-fda-breakthrough-therapy-designation-granted-for-pevonedistat-for-the-treatment-of-patients-with-higher-risk-myelodysplastic-syndromes-hr-mds/ Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the... Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the Treatment of Patients with Higher-Risk Myelodysplastic Syndromes... u s fda breakthrough therapy https://www.jnj.com/media-center/press-releases/johnson-johnson-covid-19-vaccine-authorized-by-u-s-fda-for-emergency-usefirst-single-shot-vaccine-in-fight-against-global-pandemic?ref=quillette.com Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use Nov 28, 2025 - Data demonstrated protection against COVID-19 related hospitalization and death, across countries with different variants Available on not-for-profit basis for... johnson covid 19 vaccine by u https://www.intertek.com/resources/webinars/2022/webinars-us-fda-food-contact-compliance/ Webinar Downloads | U.S. FDA Food Contact Compliance Insights into achieving food contact compliance under US FDA regulations. u s fda food contact webinar downloads compliance https://www.provisionfda.com/ PCG | The U.S. FDA Regulatory Consulting Firm PCG handles the heavy lifting FDA regulatory work for our worldwide clients, allowing clients to focus in their core business. the u s fda regulatory consulting pcg firm https://investingnews.com/news/medical-device-investing/johnson-johnson-announces-submission-of-application-to-the-u.s.fda-for-emergency-use-authorization-of-its-investigational-single-shot-janssen-covid-19-vaccine-candidate/ Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use... the u s https://www.biospace.com/beximco-pharmaceuticals-completes-u-s-fda-audit Beximco Pharmaceuticals Completes U.S. FDA Audit - BioSpace u s fda beximco pharmaceuticals completes audit https://www.finanznachrichten.de/nachrichten-2026-03/68038562-denali-therapeutics-inc-denali-therapeutics-announces-u-s-fda-approval-of-avlayah-tividenofusp-alfa-eknm-for-treatment-of-hunter-syndrome-mps-ii-399.htm Denali Therapeutics Inc.: Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH (tividenofusp... First new FDA-approved treatment option in nearly 20 years for families living with this rare lysosomal storage diseaseFirst FDA-approved medicine in emerging... u s fda denali therapeutics inc announces https://www.biospace.com/u-s-fda-accepts-biologics-license-application-for-gc-biopharma-s-gc5107b-immune-globulin-intravenous-human-10-percent-liquid U.S. FDA Accepts Biologics License Application for GC Biopharma's GC5107B (Immune Globulin... Jul 31, 2023 - GC Biopharma, a global biopharmaceutical company dedicated to specialty plasma-derived therapeutics, announced that the U.S. Food and Drug Administration has... u s fda biologics license application https://www.prweb.com/releases/u_s_fda_publishes_draft_approach_to_identifying_high_risk_foods/prweb11553826.htm U.S. FDA Publishes Draft Approach to Identifying High-Risk Foods Hampton, Virginia (PRWEB) February 05, 2014 -- On February 4, 2014, the U.S. Food and Drug Administration (FDA) published a draft approach to identifying... u s fda high risk publishes draft https://www.globenewswire.com/news-release/2025/04/29/3070088/0/en/incyclix-bio-granted-u-s-fda-fast-track-designation-for-inx-315-to-treat-ccne1-amplified-platinum-resistant-refractory-ovarian-cancer.html Incyclix Bio Granted U.S. FDA Fast Track Designation for Fast Track designation highlights potential of INX-315 to address unmet need for patients with recurrent advanced/metastatic cancer... u s fda fast track designation bio granted https://www.biospace.com/nuvalent-receives-u-s-fda-breakthrough-therapy-designation-for-nvl-655 Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655 - BioSpace May 16, 2024 - Nuvalent, Inc. (Nasdaq: NUVL) today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to NVL-655... u s fda breakthrough therapy https://www.marketscreener.com/news/u-s-fda-withdraws-gsk-s-approval-of-wellcovorin-bloomberg-news-ce7e50d8da8bfe20 U.S. FDA withdraws GSK's approval of Wellcovorin - Bloomberg news | MarketScreener Apr 9, 2026 - April 9 - U.S. FDA withdraws GSK's approval of Wellcovorin - Bloomberg news ... u s fda bloomberg news withdraws gsk https://www.globenewswire.com/news-release/2025/02/26/3032866/0/en/U-S-FDA-Accepts-Supplemental-New-Drug-Application-for-Arcutis-ZORYVE-roflumilast-Cream-0-05-for-the-Treatment-of-Children-Aged-2-to-5-with-Mild-to-Moderate-Atopic-Dermatitis.html U.S. FDA Accepts Supplemental New Drug Application for U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025 ... u s fda new drug application accepts supplemental https://www.cargill.com/story/cargill-statement-on-u.s.-fda-notice-on-partially-hydrogenated-o Cargill statement on U.S. FDA notice on partially hydrogenated oils | Cargill u s fda partially hydrogenated cargill statement notice https://www.businesswire.com/news/home/20250709101924/en/U.S.-FDA-Grants-Artera-Breakthrough-Device-Designation-for-AI-Powered-Software-Transforming-Prostate-Cancer-Care U.S. FDA Grants Artera Breakthrough Device Designation for AI-Powered Software Transforming... Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug ... u s fda https://www.biospace.com/anika-therapeutics-announces-regulatory-submissions-with-u-s-fda-and-european-regulatory-authorities-for-cingal Anika Therapeutics Announces Regulatory Submissions With U.S. FDA And European Regulatory... u s fda anika therapeutics regulatory submissions announces https://finviz.com/news/342681/artivion-announces-us-fda-approval-of-the-nexus-aortic-arch-system Artivion Announces U.S. FDA Approval of the NEXUS Aortic Arch System Stock screener for investors and traders, financial visualizations. u s fda https://www.cbsnews.com/news/coronavirus-human-drug-shortage-food-drug-administration/ Coronavirus outbreak causes first drug shortage in U.S., FDA says - CBS News Antibiotics and anesthetics especially at risk, agency warns, as up to 90% of their ingredients come from China. u s fda https://finviz.com/news/345666/us-fda-grants-priority-review-to-sbla-for-padcev-keytruda-as-perioperative-treatment-for-muscle-invasive-bladder-cancer-regardless-of-cisplatin-eligibility U.S. FDA Grants Priority Review to sBLA for PADCEV + Keytruda as Perioperative Treatment for... Stock screener for investors and traders, financial visualizations. u s fda https://www.globenewswire.com/news-release/2025/04/15/3061608/0/en/Atsena-Therapeutics-Granted-U-S-FDA-Regenerative-Medicine-Advanced-Therapy-Designation-for-ATSN-201-Gene-Therapy-to-Treat-X-linked-Retinoschisis.html Atsena Therapeutics Granted U.S. FDA Regenerative Medicine Marks fourth FDA designation for ATSN-201, which has also received Fast Track, Rare Pediatric Disease and Orphan Drug Designations... u s fda therapeutics granted regenerative medicine https://www.globenewswire.com/news-release/2024/05/30/2891040/13009/en/Catalyst-Pharmaceuticals-Receives-U-S-FDA-Approval-For-Increased-Maximum-Daily-Dose-For-FIRDAPSE.html Catalyst Pharmaceuticals Receives U.S. FDA Approval For CORAL GABLES, Fla., May 30, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ( u s fda catalyst pharmaceuticals receives approval https://www.takeda.com/en-us/newsroom/news-releases/2019/takeda-receives-us-fda-approval-to-manufacture-flexbumin/ Takeda receives U.S. FDA Approval to Manufacture FLEXBUMIN Takeda receives U.S. FDA Approval to Manufacture FLEXBUMIN u s fda takeda receives approval manufacture https://www.biospace.com/89bio-announces-u-s-fda-has-granted-breakthrough-therapy-designation-for-pegozafermin-in-nonalcoholic-steatohepatitis-nash 89bio Announces U.S. FDA has Granted Breakthrough Therapy Designation for Pegozafermin in... Sep 21, 2023 - 89bio, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to pegozafermin in patients with... u s fda https://www.finanznachrichten.de/nachrichten-2026-04/68181011-kymera-therapeutics-inc-kymera-therapeutics-announces-u-s-fda-fast-track-designation-for-kt-621-a-first-in-class-oral-stat6-degrader-for-the-tre-399.htm Kymera Therapeutics, Inc.: Kymera Therapeutics Announces U.S. FDA Fast Track Designation for... KT-621 BREADTH Phase 2b asthma trial ongoing, with data expected to be reported in late 2027 KT-621 BROADEN2 Phase 2b atopic dermatitis (AD) trial ongoing,... u s fda fast track designation kymera therapeutics inc https://www.novartis.com/news/media-releases/novartis-receives-complete-response-letter-from-us-fda-inclisiran Novartis receives complete response letter from U.S. FDA for inclisiran | Novartis complete response letter from u novartis receives https://www.biospace.com/b-janssen-pharmaceuticals-inc-b-release-u-s-fda-approves-invega-trinza-first-and-only-four-times-a-year-treatment-for-schizophrenia Janssen Pharmaceuticals, Inc. Release: U.S. FDA Approves INVEGA TRINZA, First and Only... janssen pharmaceuticals inc https://www.prnewswire.com/news-releases/us-fda-grants-breakthrough-device-designation-to-laguna-diagnostics-mrna-gene-biomarker-test-to-aid-in-differentiation-of-schizophrenia-and-bipolar-i-disorder-302754918.html U.S. FDA Grants Breakthrough Device Designation to Laguna Diagnostics' mRNA Gene Biomarker Test to... /PRNewswire/ -- Laguna Diagnostics, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the... u s fda https://www.finanznachrichten.de/nachrichten-2026-04/68115536-ultragenyx-pharmaceutical-inc-ultragenyx-announces-u-s-fda-acceptance-of-bla-resubmission-for-ux111-aav-gene-therapy-to-treat-sanfilippo-syndrome-t-399.htm Ultragenyx Pharmaceutical Inc.: Ultragenyx Announces U.S. FDA Acceptance of BLA Resubmission for... If approved, UX111 will be the first approved therapy for the treatment of Sanfilippo syndrome Type A, a rare disease affecting young children that leads to... ultragenyx pharmaceutical inc https://gmis.co/ GMIS - Get U.S. FDA Market Clearance and Approval For Your Medical Device Global Medical Innovation Solutions (GMIS) is a management consultancy and regulatory outsourcing company with a focus on the U.S. market for medical devices.... u s fda https://www.prnewswire.co.uk/news-releases/endo-announces-us-fda-approval-of-ephedrine-sulfate-injection-usp-612207463.html Endo Announces U.S. FDA Approval of Ephedrine Sulfate Injection, USP /PRNewswire/ -- Endo International plc (NASDAQ / TSX: ENDP) announced today that one of its operating companies, Par Pharmaceutical has received final... u s fda ephedrine sulfate endo announces https://www.globenewswire.com/de/news-release/2025/04/29/3070088/0/en/incyclix-bio-granted-u-s-fda-fast-track-designation-for-inx-315-to-treat-ccne1-amplified-platinum-resistant-refractory-ovarian-cancer.html Incyclix Bio Granted U.S. FDA Fast Track Designation for Fast Track designation highlights potential of INX-315 to address unmet need for patients with recurrent advanced/metastatic cancer... u s fda fast track designation bio granted https://www.biospace.com/actavis-receives-u-s-fda-approval-for-avycaz-ceftazidime-avibactam Actavis Receives U.S. FDA Approval For AVYCAZ (CEFTAZIDIME-AVIBACTAM) - BioSpace u s fda ceftazidime avibactam actavis receives