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 »
Health TidingsCHMP Backs Opzelura Cream for Moderate Atopic Dermatitis in Adults Across E... CHMP Backs Opzelura Cream for Moderate Atopic Dermatitis in Adults Across E... Read Post »
Health TidingsEMA Panel Recommends Revoking EU Approval of TAVNEOS; CSL Reaffirms Commitm... EMA Panel Recommends Revoking EU Approval of TAVNEOS; CSL Reaffirms Commitm... Read Post »
Health TidingsXspray Advances FDA Reviews of Nilopki and Dasynoc as Key Regulatory Milest... Xspray Advances FDA Reviews of Nilopki and Dasynoc as Key Regulatory Milest... Read Post »
GenericsLupin Receives U.S. FDA Tentative Approval for Generic Enzalutamide Tablets Lupin Receives U.S. FDA Tentative Approval for Generic Enzalutamide Tablets Read Post »
Health Tidings Mergers & AcquisitionsMerck KGaA to Acquire Bio-Techne for $11.3 Billion to Expand Life Science P... Merck KGaA to Acquire Bio-Techne for $11.3 Billion to Expand Life Science P... Read Post »
Health TidingsRecce Raises A$4 Million to Advance R327 Trial in DFI Recce Raises A$4 Million to Advance R327 Trial in DFI Read Post »
Health TidingsMHRA Validates Eisai’s Taletrectinib for ROS1-Positive Lung Cancer MHRA Validates Eisai’s Taletrectinib for ROS1-Positive Lung Cancer Read Post »
Health Tidings Mergers & AcquisitionsNovartis Partners With Antares in Up to $1.9 Billion Oncology Drug Deal Novartis Partners With Antares in Up to $1.9 Billion Oncology Drug Deal Read Post »
Health TidingsMHRA Approves Pediatric Investigation Plan for Ebstrocel in RDEB MHRA Approves Pediatric Investigation Plan for Ebstrocel in RDEB Read Post »
Health Tidings Mergers & AcquisitionsIonis Partners with Recordati to Commercialize Zilganersen for Alexander Di... Ionis Partners with Recordati to Commercialize Zilganersen for Alexander Di... Read Post »
Health TidingsOllin Raises $330 Million to Advance Phase 3 Trials of VEGF/Ang2 Bispecific... Ollin Raises $330 Million to Advance Phase 3 Trials of VEGF/Ang2 Bispecific... Read Post »
Health Tidings Mergers & AcquisitionsEli Lilly Expands Abbisko Alliance in Up to $1.9 Billion Multi-Target Drug ... Eli Lilly Expands Abbisko Alliance in Up to $1.9 Billion Multi-Target Drug ... Read Post »
Health TidingsFDA Converts Tecelra to Full Approval, Broadens Label to Adolescents FDA Converts Tecelra to Full Approval, Broadens Label to Adolescents Read Post »
Health TidingsADC Therapeutics Cuts Workforce by 17% to Support ZYNLONTA Regulatory Expan... ADC Therapeutics Cuts Workforce by 17% to Support ZYNLONTA Regulatory Expan... Read Post »
Health TidingsFDA Clears Phase 3 Path for Entera’s Oral Osteoporosis Therapy EB613 FDA Clears Phase 3 Path for Entera’s Oral Osteoporosis Therapy EB613 Read Post »
Health TidingsNICE Recommends Cemiplimab for Recurrent or Metastatic Cervical Cancer on t... NICE Recommends Cemiplimab for Recurrent or Metastatic Cervical Cancer on t... Read Post »
Health Tidings Mergers & AcquisitionsNuvectis Adds Late-Stage NXP100 and NXP200 in Haisco Licensing Deal Nuvectis Adds Late-Stage NXP100 and NXP200 in Haisco Licensing Deal Read Post »
GenericsFDA Approves First Generic Rifapentine Tablets for Active and Latent Tuberc... FDA Approves First Generic Rifapentine Tablets for Active and Latent Tuberc... Read Post »
Health TidingsFDA Modernizes Clinical Research Through Operation TrialBlazer FDA Modernizes Clinical Research Through Operation TrialBlazer Read Post »
Health TidingsBreakthrough T1D Backs MannKind’s INHALE-1ST Trial of Afrezza in Newly Di... Breakthrough T1D Backs MannKind’s INHALE-1ST Trial of Afrezza in Newly Di... Read Post »
Health TidingsGondolaBio Reports Positive Phase 2a Results for PORT-77 in EPP GondolaBio Reports Positive Phase 2a Results for PORT-77 in EPP Read Post »
Health TidingsFDA Agrees on Phase 3 Plan for Galectin’s Belapectin in MASH Cirrhosi... FDA Agrees on Phase 3 Plan for Galectin’s Belapectin in MASH Cirrhosi... Read Post »
