Health TidingsNanoViricides Advances NV-387 Toward Phase II Trial for Bundibugyo Ebola in... NanoViricides Advances NV-387 Toward Phase II Trial for Bundibugyo Ebola in... Read Post »
Health TidingsChina Accepts Astellas’ PADCEV Plus Keytruda Filing for Muscle-Invasi... China Accepts Astellas’ PADCEV Plus Keytruda Filing for Muscle-Invasi... Read Post »
Health TidingsFDA Accepts Organogenesis’ ReNu® BLA for Symptomatic Knee Osteoarthr... FDA Accepts Organogenesis’ ReNu® BLA for Symptomatic Knee Osteoarthr... Read Post »
Health Tidings Mergers & AcquisitionsVertex to Acquire Crinetics for $10 Billion, Adding PALSONIFY and Phase 3 A... Vertex to Acquire Crinetics for $10 Billion, Adding PALSONIFY and Phase 3 A... Read Post »
GenericsGlenmark Launches Generic Olanzapine for Injection in the US, Expanding Ins... Glenmark Launches Generic Olanzapine for Injection in the US, Expanding Ins... Read Post »
Health Tidings Mergers & AcquisitionsAstex Signs Breast Cancer Drug Discovery Deal with Genentech Astex Signs Breast Cancer Drug Discovery Deal with Genentech Read Post »
Health TidingsImmuron Engages Pullan Consulting to Drive IMM-529 Commercial Partnership Immuron Engages Pullan Consulting to Drive IMM-529 Commercial Partnership Read Post »
Health TidingsCelea Raises $180 Million to Launch Phase 3 SURPASS-IPF Trial of Deupirfeni... Celea Raises $180 Million to Launch Phase 3 SURPASS-IPF Trial of Deupirfeni... Read Post »
Health TidingsAscletis Files Dual FDA INDs for Ultra‑Long‑Acting Obesity Therapies Ta... Ascletis Files Dual FDA INDs for Ultra‑Long‑Acting Obesity Therapies Ta... Read Post »
Health Tidings Mergers & AcquisitionsNovartis Acquires Myricx Bio to Advance Novel ADC Payload Technology Novartis Acquires Myricx Bio to Advance Novel ADC Payload Technology Read Post »
Health TidingsMHRA Calls for Faster Regulation to Accelerate Medical Innovation MHRA Calls for Faster Regulation to Accelerate Medical Innovation Read Post »
Health TidingsNewron Maps FDA Path Forward for Evenamide Phase 3 Trial Newron Maps FDA Path Forward for Evenamide Phase 3 Trial Read Post »
Health TidingsCincinnati Children’s Phase 2 Trial Shows WRSs2 Shigella Vaccine Achi... Cincinnati Children’s Phase 2 Trial Shows WRSs2 Shigella Vaccine Achi... Read Post »
Health TidingsNature Publication Strengthens Arcus’ Casdatifan Program in Advanced ... Nature Publication Strengthens Arcus’ Casdatifan Program in Advanced ... Read Post »
Health TidingsFDA Issues Complete Response Letter to Ascelia Pharma’s Orviglance ND... FDA Issues Complete Response Letter to Ascelia Pharma’s Orviglance ND... Read Post »
Health Tidings Mergers & AcquisitionsArcturus Therapeutics Announces Strategic Collaboration with Thermo Fisher ... Arcturus Therapeutics Announces Strategic Collaboration with Thermo Fisher ... Read Post »
GenericsEMA Expands Lupin’s NaMuscla Approval to Include Children with Non-Dystro... EMA Expands Lupin’s NaMuscla Approval to Include Children with Non-Dystro... Read Post »
Health Tidings Mergers & AcquisitionsTakeda Partners With Insilico Medicine in AI Drug Discovery Deal Worth Up t... Takeda Partners With Insilico Medicine in AI Drug Discovery Deal Worth Up t... Read Post »
Health Tidings Regulatory & Health Policy Women & Child HealthEMA Moves to Embed Women’s Health Across Europe’s Medicines Reg... EMA Moves to Embed Women’s Health Across Europe’s Medicines Reg... Read Post »
Health Tidings Mergers & AcquisitionsUnited Therapeutics Acquires Thymmune to Expand T-Cell Regeneration Researc... United Therapeutics Acquires Thymmune to Expand T-Cell Regeneration Researc... Read Post »
Health TidingsJCO Study Supports FDA Approval of BIZENGRI in NRG1+ Cholangiocarcinoma JCO Study Supports FDA Approval of BIZENGRI in NRG1+ Cholangiocarcinoma Read Post »
Health TidingsMHRA Starts Evaluation of Eisai’s Lemborexant for Adult Insomnia MHRA Starts Evaluation of Eisai’s Lemborexant for Adult Insomnia Read Post »
Health TidingsAbbisko, AstraZeneca Partner to Advance Oral PD-L1 Inhibitor and Tagrisso C... Abbisko, AstraZeneca Partner to Advance Oral PD-L1 Inhibitor and Tagrisso C... Read Post »
Health TidingsTelix Secures FDA Alignment to Advance ProstACT Global Trial of TLX591-Tx i... Telix Secures FDA Alignment to Advance ProstACT Global Trial of TLX591-Tx i... Read Post »
GenericsSamsung Bioepis Relaunches BYOOVIZ® in the US Through Harrow Partnership Samsung Bioepis Relaunches BYOOVIZ® in the US Through Harrow Partnership Read Post »
Health TidingsTerrestrial Begins First-in-Human Trial of Needle-Free Semaglutide Microarr... Terrestrial Begins First-in-Human Trial of Needle-Free Semaglutide Microarr... Read Post »
Health Tidings Mergers & AcquisitionsIpsen Acquires Memo Therapeutics, Adds Potravitug to Rare Disease Pipeline Ipsen Acquires Memo Therapeutics, Adds Potravitug to Rare Disease Pipeline Read Post »
Health TidingsGalderma Receives FDA Complete Response Letter for Relfydess BLA; Manufactu... Galderma Receives FDA Complete Response Letter for Relfydess BLA; Manufactu... Read Post »
Health TidingsKowa Submits FDA NDA for Nicox’s NCX 470 in Open-Angle Glaucoma and O... Kowa Submits FDA NDA for Nicox’s NCX 470 in Open-Angle Glaucoma and O... Read Post »
Health TidingsMesoblast Files FDA BLA for Rexlemestrocel-L to Prevent GI Bleeding in LVAD... Mesoblast Files FDA BLA for Rexlemestrocel-L to Prevent GI Bleeding in LVAD... Read Post »
Health TidingsAzurity Acquires CONTRAVE to Expand into Obesity Treatment Azurity Acquires CONTRAVE to Expand into Obesity Treatment Read Post »
Health TidingsFDA Approves Orca Bio’s TREGZI to Improve Chronic GVHD-Free Survival ... FDA Approves Orca Bio’s TREGZI to Improve Chronic GVHD-Free Survival ... Read Post »
Health TidingsSarepta’s Duchenne Drugs AMONDYS 45 and VYONDYS 53 Advance Toward Full FD... Sarepta’s Duchenne Drugs AMONDYS 45 and VYONDYS 53 Advance Toward Full FD... Read Post »
Health TidingsFDA Issues Second CRL for Unicycive’s Oxylanthanum Carbonate NDA FDA Issues Second CRL for Unicycive’s Oxylanthanum Carbonate NDA Read Post »
Health TidingsCogent Biosciences Submits NDA for Bezuclastinib in Advanced Systemic Masto... Cogent Biosciences Submits NDA for Bezuclastinib in Advanced Systemic Masto... Read Post »
Health TidingsFDA Grants Three-Month Review Extension for Relutrigine NDA FDA Grants Three-Month Review Extension for Relutrigine NDA Read Post »
Health Tidings Mergers & AcquisitionsInnovent Secures Exclusive China Rights to Lilly’s Verzenios Innovent Secures Exclusive China Rights to Lilly’s Verzenios Read Post »
Health TidingsREGENXBIO Initiates Phase IIb/III NAAVIGATE Trial of Sura-Vec for Diabetic ... REGENXBIO Initiates Phase IIb/III NAAVIGATE Trial of Sura-Vec for Diabetic ... Read Post »
Health TidingsFDA Accepts Roche’s Enspryng sBLA Under Priority Review for TED FDA Accepts Roche’s Enspryng sBLA Under Priority Review for TED Read Post »
Health TidingsBioCryst Ends Internal Discovery Efforts, Strengthens Focus on Clinical-Sta... BioCryst Ends Internal Discovery Efforts, Strengthens Focus on Clinical-Sta... Read Post »
Health TidingsBiohaven Starts Pivotal Phase 3 Trial of BHV-1300, the First Extracellular ... Biohaven Starts Pivotal Phase 3 Trial of BHV-1300, the First Extracellular ... Read Post »
Health TidingsCHMP Backs Hopledo for Parkinson’s Following Positive RISE-PD Results CHMP Backs Hopledo for Parkinson’s Following Positive RISE-PD Results Read Post »
Health Tidings Mergers & AcquisitionsIpsen to Acquire Kartos Therapeutics in Up to $1.75B Deal, Adds Myelofibros... Ipsen to Acquire Kartos Therapeutics in Up to $1.75B Deal, Adds Myelofibros... Read Post »
Health TidingsFDA Issues Complete Response Letter for Sobi’s NASP in Uncontrolled G... FDA Issues Complete Response Letter for Sobi’s NASP in Uncontrolled G... Read Post »
Health TidingsModerna Highlights Expanding mRNA Pipeline Beyond Vaccines with Oncology Moderna Highlights Expanding mRNA Pipeline Beyond Vaccines with Oncology Read Post »
Health TidingsEMA CHMP Issues Negative Opinion on Narsoplimab for TA-TMA; Omeros to Seek ... EMA CHMP Issues Negative Opinion on Narsoplimab for TA-TMA; Omeros to Seek ... Read Post »
Health TidingsFDA Issues Complete Response Letter for Lantheus’ LNTH-2501 PET Imagi... FDA Issues Complete Response Letter for Lantheus’ LNTH-2501 PET Imagi... Read Post »
Health Tidings Mergers & AcquisitionsElixirgen and Nippon Shinyaku Partner to Advance Full-Length Dystrophin mRN... Elixirgen and Nippon Shinyaku Partner to Advance Full-Length Dystrophin mRN... Read Post »
Health TidingsFDA Schedules Advisory Committee Review of Deramiocel BLA for DMD FDA Schedules Advisory Committee Review of Deramiocel BLA for DMD Read Post »
Health TidingsFDA Accepts Replimune’s RP1 BLA Resubmission for Advanced Melanoma FDA Accepts Replimune’s RP1 BLA Resubmission for Advanced Melanoma Read Post »
