https://novapharmanews.com/us/news/fda-draft-guidance-payor-communications-rules 2026-06-13T06:06:40.893Z NovaPharmaNews en 2026-06-13T06:06:40.933Z FDA Draft Guidance Updates Payor Communications Rules https://novapharmanews.com/uploads/articles/fda-draft-guidance-payor-communications-rules.webp FDA Draft Guidance Updates Payor Communications Rules https://novapharmanews.com/eu/news/mhra-targets-medicine-safety-with-new-ai-sandbox 2026-06-13T04:44:06.347Z NovaPharmaNews en 2026-06-13T04:44:06.348Z MHRA targets medicine safety with new AI sandbox https://novapharmanews.com/uploads/articles/mhra-targets-medicine-safety-with-new-ai-sandbox.webp MHRA targets medicine safety with new AI sandbox https://novapharmanews.com/eu/news/biocryst-new-orladeyo-data-real-world-evidence-hae 2026-06-13T04:44:05.747Z NovaPharmaNews en 2026-06-13T04:44:05.748Z BioCryst’s New ORLADEYO Data Adds Real-World HAE Evidence ORLADEYO, berotralstat, HAE, hereditary angioedema https://novapharmanews.com/uploads/articles/biocryst-new-orladeyo-data-real-world-evidence-hae.webp BioCryst’s New ORLADEYO Data Adds Real-World HAE Evidence https://novapharmanews.com/eu/news/ema-researchers-map-ai-research-priorities-across-the-medicines-lifecycle 2026-06-13T04:44:04.881Z NovaPharmaNews en 2026-06-13T04:44:04.934Z EMA researchers map AI research priorities across the medicines lifecycle https://novapharmanews.com/uploads/articles/ema-researchers-map-ai-research-priorities-across-the-medicines-lifecycle.webp EMA researchers map AI research priorities across the medicines lifecycle https://novapharmanews.com/us/news/alembic-tentative-fda-approval-generic-larotrectinib-capsules 2026-06-13T06:31:29.976Z NovaPharmaNews en 2026-06-13T01:03:15.888Z Alembic Wins Tentative FDA Nod for First Generic Larotrectinib Capsules larotrectinib, Vitrakvi, NTRK fusion–positive solid tumors, solid tumors https://novapharmanews.com/uploads/articles/alembic-tentative-fda-approval-generic-larotrectinib-capsules.webp Alembic Wins Tentative FDA Nod for First Generic Larotrectinib Capsules https://novapharmanews.com/eu/news/truqap-us-approval-pten-deficient-metastatic-prostate-cancer 2026-06-13T04:54:25.631Z NovaPharmaNews en 2026-06-13T00:35:26.866Z Truqap gains US approval in PTEN-deficient metastatic prostate cancer Truqap, capivasertib, lutetium Lu 177 vipivotide tetraxetan, Pluvicto, abiraterone, prednisone, prostate cancer, PTEN-deficient metastatic hormone-sensitive prostate cancer, prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer, mCRPC https://novapharmanews.com/uploads/articles/truqap-us-approval-pten-deficient-metastatic-prostate-cancer.webp Truqap gains US approval in PTEN-deficient metastatic prostate cancer https://novapharmanews.com/us/news/fda-clears-first-otc-cgm-for-children-dexcom-stelo 2026-06-13T06:02:19.151Z NovaPharmaNews en 2026-06-13T00:07:10.284Z FDA Clears First OTC CGM for Children: Dexcom Expands Stelo Stelo Glucose Biosensor System, diabetes https://novapharmanews.com/uploads/articles/fda-clears-first-otc-cgm-for-children-dexcom-stelo.webp FDA Clears First OTC CGM for Children: Dexcom Expands Stelo https://novapharmanews.com/us/news/fda-priority-review-belzutifan-pembrolizumab-adjuvant-renal-cell-carcinoma 2026-06-13T06:30:12.344Z NovaPharmaNews en 2026-06-12T22:11:11.101Z FDA priority review advances belzutifan plus pembrolizumab in adjuvant RCC belzutifan, Welireg, pembrolizumab, Keytruda, berahyaluronidase alfa-pmph, Keytruda Qlex, adjuvant renal cell carcinoma, advanced renal cell carcinoma, von Hippel-Lindau disease https://novapharmanews.com/uploads/articles/fda-priority-review-belzutifan-pembrolizumab-adjuvant-renal-cell-carcinoma.webp FDA priority review advances belzutifan plus pembrolizumab in adjuvant RCC https://novapharmanews.com/us/news/chile-warning-labels-on-food-new-evidence-efficacy-obesity-risk 2026-06-13T06:31:16.854Z NovaPharmaNews en 2026-06-12T22:11:10.232Z Chile warning labels on food: new evidence on efficacy and obesity risk diabetes https://novapharmanews.com/uploads/articles/chile-warning-labels-on-food-new-evidence-efficacy-obesity-risk.webp Chile warning labels on food: new evidence on efficacy and obesity risk https://novapharmanews.com/eu/news/duty-of-care-oncology-conferences-planetary-health-research 2026-06-13T06:23:25.532Z NovaPharmaNews en 2026-06-12T04:35:39.114Z Duty of care at oncology conferences spotlights planetary health research Oncology https://novapharmanews.com/uploads/articles/duty-of-care-oncology-conferences-planetary-health-research.webp Duty of care at oncology conferences spotlights planetary health research https://novapharmanews.com/us/news/socioeconomic-status-shapes-childrens-brain-development-study-finds 2026-06-12T23:12:35.819Z NovaPharmaNews en 2026-06-12T04:05:06.994Z Socioeconomic status shapes children’s brain development, study finds https://novapharmanews.com/uploads/articles/socioeconomic-status-shapes-childrens-brain-development-study-finds.webp Socioeconomic status shapes children’s brain development, study finds https://novapharmanews.com/eu/news/synthetic-real-world-data-oncology-trial-decision-making 2026-06-13T00:15:27.149Z NovaPharmaNews en 2026-06-12T01:11:57.842Z Synthetic real-world data reshapes oncology trial decision-making Oncology https://novapharmanews.com/uploads/articles/synthetic-real-world-data-oncology-trial-decision-making.webp Synthetic real-world data reshapes oncology trial decision-making https://novapharmanews.com/us/news/fda-bemotrizinol-sunscreen-regulatory-update 2026-06-13T00:59:00.278Z NovaPharmaNews en 2026-06-12T01:08:57.412Z FDA adds bemotrizinol to sunscreen rules, expanding U.S. UV filter options sunburn, skin cancer, skin aging https://novapharmanews.com/uploads/articles/fda-bemotrizinol-sunscreen-regulatory-update.webp FDA adds bemotrizinol to sunscreen rules, expanding U.S. UV filter options https://novapharmanews.com/us/news/biotech-coming-of-age-market-analysis 2026-06-12T11:44:13.224Z NovaPharmaNews en 2026-06-12T01:05:39.096Z Biotech coming of age: market analysis of a sector in transition https://novapharmanews.com/uploads/articles/biotech-coming-of-age-market-analysis.webp Biotech coming of age: market analysis of a sector in transition https://novapharmanews.com/eu/news/ema-approved-104-human-medicines-in-2025-what-changed 2026-06-13T00:13:12.997Z NovaPharmaNews en 2026-06-12T00:42:15.602Z EMA approved 104 human medicines in 2025: what changed denosumab, osteoporosis, bone https://novapharmanews.com/uploads/articles/ema-approved-104-human-medicines-in-2025-what-changed.webp EMA approved 104 human medicines in 2025: what changed 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NovaPharmaNews en 2026-06-11T20:17:02.323Z CDC data show alcohol use during pregnancy is rising again alcohol, pregnancy https://novapharmanews.com/uploads/articles/cdc-data-alcohol-use-during-pregnancy-rising-again.webp CDC data show alcohol use during pregnancy is rising again https://novapharmanews.com/us/news/sensorion-pivots-to-sens-601-after-regenerons-otof-hearing-loss-advance 2026-06-12T20:50:08.237Z NovaPharmaNews en 2026-06-11T18:15:53.448Z Sensorion pivots to SENS-601 after Regeneron’s OTOF hearing loss advance Otarmeni, lunsotogene parvec-cwha, SENS-601, SENS-501, hearing loss, OTOF-related hearing loss, deafness https://novapharmanews.com/uploads/articles/sensorion-pivots-to-sens-601-after-regenerons-otof-hearing-loss-advance.webp Sensorion pivots to SENS-601 after Regeneron’s OTOF hearing loss advance https://novapharmanews.com/us/news/takeda-tyk2-drug-tops-bristol-myers-sotyktu-psoriasis-head-to-head-test 2026-06-12T22:02:15.925Z NovaPharmaNews en 2026-06-11T16:14:54.373Z Takeda TYK2 drug tops Bristol Myers’ Sotyktu in psoriasis head-to-head test zasocitinib, Sotyktu, psoriasis https://novapharmanews.com/uploads/articles/takeda-tyk2-drug-tops-bristol-myers-sotyktu-psoriasis-head-to-head-test.webp Takeda TYK2 drug tops Bristol Myers’ Sotyktu in psoriasis head-to-head test https://novapharmanews.com/us/news/fda-guidance-human-factors-information-marketing-submissions 2026-06-13T05:46:06.247Z NovaPharmaNews en 2026-06-11T14:14:56.429Z FDA Issues Guidance on Human Factors Information in Marketing Submissions https://novapharmanews.com/uploads/articles/fda-guidance-human-factors-information-marketing-submissions.webp FDA Issues Guidance on Human Factors Information in Marketing Submissions https://novapharmanews.com/us/news/fda-authorizes-generic-nitenpyram-new-world-screwworm-pets 2026-06-12T17:36:57.078Z NovaPharmaNews en 2026-06-11T14:14:55.531Z FDA authorizes generic nitenpyram for New World screwworm in pets Nitenpyram, New 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amid cancer-warning debate https://novapharmanews.com/apac/news/blood-pressure-ischemic-stroke-risk-dementia-nationwide-cohort 2026-06-12T22:10:31.449Z NovaPharmaNews en 2026-06-11T12:05:43.419Z Blood pressure and ischemic stroke risk in dementia: nationwide cohort findings ischemic stroke, dementia, hypertension https://novapharmanews.com/uploads/articles/blood-pressure-ischemic-stroke-risk-dementia-nationwide-cohort.webp Blood pressure and ischemic stroke risk in dementia: nationwide cohort findings https://novapharmanews.com/us/news/sepsis-ai-algorithms-need-real-time-data-not-hindsight 2026-06-12T17:29:56.052Z NovaPharmaNews en 2026-06-11T10:07:14.604Z Sepsis AI algorithms need real-time data, not hindsight sepsis https://novapharmanews.com/uploads/articles/sepsis-ai-algorithms-need-real-time-data-not-hindsight.webp Sepsis AI algorithms need real-time data, not hindsight https://novapharmanews.com/eu/news/ema-approves-tx01-pip-unlocking-puma-pathway-theranexus-exeltis 2026-06-12T18:23:17.936Z NovaPharmaNews en 2026-06-11T08:35:44.588Z EMA approves TX01 PIP, unlocking the PUMA pathway for Theranexus and Exeltis TX01 https://novapharmanews.com/uploads/articles/ema-approves-tx01-pip-unlocking-puma-pathway-theranexus-exeltis.webp EMA approves TX01 PIP, unlocking the PUMA pathway for Theranexus and Exeltis