https://www.pharmanow.live/latest-news/fda-refreshes-drug-approvals-databases-portal-regulatory-tools 2026-10-28T22:02:34+05:30 Pharma Now en 2026-10-28T00:00:00+05:30 FDA Refreshes Drug Approvals and Databases Portal Across 20 Regulatory Tools FDA https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/agents-data/images/news/38a87a9d-75e9-4c46-93e7-4af5e584f852/9f66f391-eb04-46a2-b79c-0b29e8bae8e3.png https://www.pharmanow.live/latest-news/fda-21st-century-cures-act-eua-gmp-waiver-mcm-manufacturers 2026-10-28T22:03:46+05:30 Pharma Now en 2026-10-28T00:00:00+05:30 FDA's 21st Century Cures Act Reshapes EUA Authority and GMP Waiver Powers for MCM Manufacturers FDA https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/agents-data/images/news/38a87a9d-75e9-4c46-93e7-4af5e584f852/fe2790ff-1265-42f9-8f61-48837a9da68d.png https://www.pharmanow.live/latest-news/fda-tropical-disease-priority-review-voucher-guidance-fdaaa-section-524 2026-10-28T22:05:18+05:30 Pharma Now en 2026-10-28T00:00:00+05:30 FDA Reissues Tropical Disease Priority Review Voucher Guidance FDA https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/agents-data/images/news/38a87a9d-75e9-4c46-93e7-4af5e584f852/6569a7fb-6b43-41c7-bda2-f71340b80e1d.png https://www.pharmanow.live/latest-news/benitec-biopharma-bb-301-phase-1b-2a-opmd-interim-results 2026-10-28T22:06:48+05:30 Pharma Now en 2026-10-28T00:00:00+05:30 Benitec Biopharma Achieves 100% Response Rate in BB-301 Study for OPMD Benitec https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/agents-data/images/news/0b2396d5-33ac-4143-8bb5-99e6aecd9639/26c05853-f658-406c-b9b2-e369e3f35be8.png https://www.pharmanow.live/latest-news/teva-acquires-bioxcel-assets-at-home-acute-agitation-treatment 2026-10-28T22:08:34+05:30 Pharma Now en 2026-10-28T00:00:00+05:30 Teva Acquires BioXcel Assets to Advance First At-Home Acute Agitation Treatment Teva https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/agents-data/images/news/6aeb94bc-922c-495f-976f-d5fe852a8a4c/92710a3c-c2b0-44b1-b615-eadf73c442b4.png https://www.pharmanow.live/latest-news/sudeep-pharma-fda-approval-nandesari-gujarat-facility-h2-fy27 2026-10-28T22:09:34+05:30 Pharma Now en 2026-10-28T00:00:00+05:30 Sudeep Pharma Gains FDA Approval for Nandesari Gujarat Facility Sudeep https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/agents-data/images/news/6aeb94bc-922c-495f-976f-d5fe852a8a4c/67d2440f-a78c-4c04-b6bc-25a7ae313220.png https://www.pharmanow.live/latest-news/jubilant-biosys-appoints-dr-sk-dhakshinamoorthy-senior-vp-strategy-value-creation 2026-10-28T22:10:25+05:30 Pharma Now en 2026-10-28T00:00:00+05:30 Jubilant Biosys Appoints Dr. SK Dhakshinamoorthy as Senior VP Jubilant https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/agents-data/images/news/50932806-a97a-4df0-b3af-d4e36ada19d6/d340934d-c689-42e4-8680-6f5fad4f4674.png https://www.pharmanow.live/latest-news/neilmed-pharmaceuticals-fda-warning-letter-glycerin-identity-testing-2023 2026-10-28T11:12:09+05:30 Pharma Now en 2026-10-27T00:00:00+05:30 FDA Flags NeilMed Glycerin Testing Failures in Warning Letter FDA https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/uploads/news/original/fda-neilmed-pharmaceuticals-warning-letter-glycerin-identity-testing-202320261028111126.webp https://www.pharmanow.live/latest-news/neilmed-pharmaceuticals-fda-warning-letter-closeout-2026 2026-10-28T12:35:30+05:30 Pharma Now en 2026-10-27T00:00:00+05:30 NeilMed Secures FDA Warning Letter Closeout After CAPA Recovery NeilMed https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/uploads/news/original/neilmed-fda-warning-letter-closeout-capa-recovery-202620261028123508.webp https://www.pharmanow.live/latest-news/fda-draft-guidance-bla-individualized-genome-editing-products-2026 2026-10-28T12:16:27+05:30 Pharma Now en 2026-10-27T00:00:00+05:30 FDA Draft Guidance Addresses Individualized Genome Editing BLAs FDA https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/uploads/news/original/fda-individualized-genome-editing-bla-draft-guidance-202620261028121442.webp https://www.pharmanow.live/latest-news/beaute-bounty-fda-cber-warning-letter-unlicensed-stem-cell-placenta-biologics 2026-10-27T22:41:21+05:30 Pharma Now en 2026-10-27T00:00:00+05:30 Beaute Bounty Receives FDA CBER Warning Letter for Unlicensed Stem Cell and Placenta Biologics FDA https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/agents-data/images/news/0795ad9d-77bc-41db-a6ce-70cad0128da0/924a3082-0ed0-41f6-af47-65c2aa5ee72c.png https://www.pharmanow.live/latest-news/fda-warning-letter-best-chinese-medicines-llc-unapproved-drugs-2026 2026-10-28T12:04:06+05:30 Pharma Now en 2026-10-27T00:00:00+05:30 FDA Warns Best Chinese Medicines LLC Over Five Unapproved Drugs FDA https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/uploads/news/original/fda-best-chinese-medicines-warning-letter-five-unapproved-drugs-202620261028120318.webp https://www.pharmanow.live/latest-news/alembic-pharmaceuticals-usfda-final-approval-valganciclovir-oral-solution-cmv-retinitis 2026-10-28T11:58:47+05:30 Pharma Now en 2026-10-27T00:00:00+05:30 Alembic Wins USFDA Approval for Valganciclovir Oral Solution Alembic https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/uploads/news/original/alembic-usfda-valganciclovir-oral-solution-approval-cmv-retinitis-202620261028115749.webp https://www.pharmanow.live/latest-news/abbvie-submits-bla-etentamig-fda-relapsed-refractory-multiple-myeloma 2026-10-28T11:53:06+05:30 Pharma Now en 2026-10-27T00:00:00+05:30 AbbVie Submits FDA Application for Etentamig in Multiple Myeloma AbbVie https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/uploads/news/original/abbvie-etentamig-bla-fda-relapsed-refractory-multiple-myeloma-202620261028115212.webp 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2026-10-27T00:00:00+05:30 Lilly Reports Durable Olomorasib Responses in KRAS Lung Cancer Lilly https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/uploads/news/original/lilly-olomorasib-kras-g12c-lung-cancer-durable-responses-esmo-202620261028105044.webp https://www.pharmanow.live/latest-news/biontech-bms-pumitamig-lung-cancer-367-response-rate 2026-10-28T10:43:22+05:30 Pharma Now en 2026-10-27T00:00:00+05:30 BioNTech Reports 36.7% Response Rate for Pumitamig in Lung Cancer BioNTech https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/uploads/news/original/biontech-bms-pumitamig-36-7-response-rate-lung-cancer-202620261028104106.webp https://www.pharmanow.live/latest-news/zyduss-moraiya-plant-closes-fda-inspection-with-5-observations 2026-10-27T07:47:24+05:30 Pharma Now en 2026-10-16T00:00:00+05:30 Zydus's Moraiya plant closes FDA inspection with 5 observations FDA Inspection, Zydus Lifesciences, Warning Letter, 483 Form https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/uploads/news/original/moraiyafact-01-jpg20261027071220.jpg https://www.pharmanow.live/latest-news/pfizer-fda-approval-talazoparib-enzalutamide-hrr-mutated-mapms-prostate-cancer 2026-10-27T07:46:01+05:30 Pharma Now en 2026-10-27T00:00:00+05:30 Pfizer Gains FDA Approval for Talazoparib Plus Enzalutamide in HRR-Mutated mAPMN/S Prostate Cancer talazoparib, Prostate Cancer, Pfizer https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/uploads/news/original/Pfizer_HQ_Entrance_1600X900_opt20261027074057.jpg https://www.pharmanow.live/latest-news/hepion-pharmaceuticals-fda-feedback-gv104-fentanyl-prophylaxis-nda 2026-10-27T10:49:22+05:30 Pharma Now en 2026-10-26T00:00:00+05:30 Hepion Pharmaceuticals Gains FDA Backing for GV104 Modeling Hepion https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/uploads/news/original/hepion-gv104-fda-feedback-fentanyl-prophylaxis-modeling-202620261027104648.webp 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for 25-Valent Infant Vaccine Pfizer https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/uploads/news/original/pfizer-25-valent-pneumococcal-vaccine-phase-2-infant-results-202620261027101902.webp https://www.pharmanow.live/latest-news/artelo-biosciences-art26-12-fabp5-inhibitor-mad-study-phase-1 2026-10-27T10:10:44+05:30 Pharma Now en 2026-10-26T00:00:00+05:30 Artelo Biosciences Advances ART26.12 Into MAD Study Artelo https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/uploads/news/original/artelo-art26-12-fabp5-inhibitor-phase-1-mad-study-q4-202620261027101028.webp https://www.pharmanow.live/latest-news/v-shapes-single-dose-packaging 2026-10-26T15:25:08+05:30 Pharma Now en 2026-10-26T00:00:00+05:30 V-Shapes Single-Dose Packaging for Nutraceuticals, Skincare V-Shapes single-dose packaging https://pharmanow.nyc3.cdn.digitaloceanspaces.com/p/uploads/news/original/v-shapes-single-dose-packaging20261026152219.webp