New Drug ApprovalNorgine Pushes the Frontier of WHIM Treatment With XOLREMDI EU Approval Norgine Pushes the Frontier of WHIM Treatment With XOLREMDI EU Approval Read Post »
Clinical TrialsTelix Advances TLX597-Tx with Positive Phase 2 Dosimetry Findings Telix Advances TLX597-Tx with Positive Phase 2 Dosimetry Findings Read Post »
New Drug ApprovalMitsubishi Tanabe Brings Steady Control to Parkinson’s with EU Nod for On... Mitsubishi Tanabe Brings Steady Control to Parkinson’s with EU Nod for On... Read Post »
Health TidingsuniQure Moves Toward UK Approval Filing for AMT-130 in Huntington’s Disea... uniQure Moves Toward UK Approval Filing for AMT-130 in Huntington’s Disea... Read Post »
Health TidingsInsilico Medicine Advances AI-Developed Rentosertib into Inhalation Trial Insilico Medicine Advances AI-Developed Rentosertib into Inhalation Trial Read Post »
Health TidingsBayer Files Asundexian in China for Secondary Stroke Prevention Bayer Files Asundexian in China for Secondary Stroke Prevention Read Post »
Health TidingsBiogen and Eisai Strengthen LEQEMBI’s Role in Alzheimer’s Treatment Biogen and Eisai Strengthen LEQEMBI’s Role in Alzheimer’s Treatment Read Post »
Regulatory & Health PolicyNICE Recommends Rozanolixizumab as New Option for Uncontrolled gMG NICE Recommends Rozanolixizumab as New Option for Uncontrolled gMG Read Post »
Clinical TrialsNovo Nordisk Strikes at the Core of Haemophilia A with Denecimig Breakthrou... Novo Nordisk Strikes at the Core of Haemophilia A with Denecimig Breakthrou... Read Post »
Mergers & AcquisitionsChiesi Seals a Strategic Win with $1.9B KalVista Acquisition Chiesi Seals a Strategic Win with $1.9B KalVista Acquisition Read Post »
Clinical TrialsNewron Hits a Regulatory Speed Bump as FDA Pauses U.S. Enrollment in ENIGMA... Newron Hits a Regulatory Speed Bump as FDA Pauses U.S. Enrollment in ENIGMA... Read Post »
Food Health Tidings Regulatory & Health PolicyWhy FDA’s Infant Formula Findings Reassure, Yet Call for Vigilance Why FDA’s Infant Formula Findings Reassure, Yet Call for Vigilance Read Post »
Clinical TrialsVeradermics Meets Endpoints with Oral VDPHL01 in Pattern Hair Loss Study Veradermics Meets Endpoints with Oral VDPHL01 in Pattern Hair Loss Study Read Post »
Clinical TrialsGilead Leverages Priority Review to Advance Bic/Len in HIV Care Gilead Leverages Priority Review to Advance Bic/Len in HIV Care Read Post »
Health TidingsBeOne Gains Ground in GEA as FDA Fast-Tracks TEVIMBRA Combo BeOne Gains Ground in GEA as FDA Fast-Tracks TEVIMBRA Combo Read Post »
Clinical TrialsPfizer Sets a New Pace in Multiple Myeloma Treatment with ELREXFIO Pfizer Sets a New Pace in Multiple Myeloma Treatment with ELREXFIO Read Post »
Clinical TrialsImmunome Reports Strong Phase 3 Data, Submits NDA for Varegacestat Immunome Reports Strong Phase 3 Data, Submits NDA for Varegacestat Read Post »
Mergers & AcquisitionsTeva to Acquire Emalex and Add Tourette Drug Ecopipam Teva to Acquire Emalex and Add Tourette Drug Ecopipam Read Post »
Clinical TrialsFDA Real-Time Trials: AstraZeneca and Amgen Lead Breakthrough FDA Real-Time Trials: AstraZeneca and Amgen Lead Breakthrough Read Post »
Mergers & AcquisitionsProfluent and Eli Lilly Chase the ‘Holy Grail’ of DNA Editing Profluent and Eli Lilly Chase the ‘Holy Grail’ of DNA Editing Read Post »
Health TidingsPfizer Extends U.S. Patent Protection for Tafamidis Drug VYNDAMAX to 2031 Pfizer Extends U.S. Patent Protection for Tafamidis Drug VYNDAMAX to 2031 Read Post »
Health Tidings Regulatory & Health PolicyMHRA and FDA Drive Changes to Improve Trial Efficiency MHRA and FDA Drive Changes to Improve Trial Efficiency Read Post »
Health TidingsQUVIVIQ Powers Idorsia Growth with Strong Sales and Expanding Clinical Evid... QUVIVIQ Powers Idorsia Growth with Strong Sales and Expanding Clinical Evid... Read Post »
Health TidingsFDA Grants Fast Track to Amyloid-Depleting Antibody Coramitug for ATTR-CM FDA Grants Fast Track to Amyloid-Depleting Antibody Coramitug for ATTR-CM Read Post »
Health TidingsGSK advances bepirovirsen with FDA priority review in hepatitis B GSK advances bepirovirsen with FDA priority review in hepatitis B Read Post »
Health TidingsFDA Takes Up Zipalertinib Application for Lung Cancer FDA Takes Up Zipalertinib Application for Lung Cancer Read Post »
New Drug ApprovalAstraZeneca’s Triple-combination inhaler Breztri approved by FDA for asth... AstraZeneca’s Triple-combination inhaler Breztri approved by FDA for asth... Read Post »
Clinical TrialsBoehringer’s survodutide Achieves Up to 16.6% Weight Loss in Phase II... Boehringer’s survodutide Achieves Up to 16.6% Weight Loss in Phase II... Read Post »
Clinical TrialsAbbVie Files Upadacitinib for FDA Approval in Alopecia Areata AbbVie Files Upadacitinib for FDA Approval in Alopecia Areata Read Post »
Health TidingsJanux discontinues JANX008 after Phase 1a results over efficacy Janux discontinues JANX008 after Phase 1a results over efficacy Read Post »
Health TidingsGilead Completes $7.8 Billion Acquisition of Arcellx, Gains Full Control of... Gilead Completes $7.8 Billion Acquisition of Arcellx, Gains Full Control of... Read Post »
Health TidingsTerns Advances TERN-701 with FDA Breakthrough Therapy Designation in CML Terns Advances TERN-701 with FDA Breakthrough Therapy Designation in CML Read Post »
Clinical TrialsMundipharma Positions REZZAYO as a Steady Shield in Fungal Prevention Study Mundipharma Positions REZZAYO as a Steady Shield in Fungal Prevention Study Read Post »
Health TidingsFDA Seeks to Withdraw TAVNEOS After Identifying Efficacy Gaps FDA Seeks to Withdraw TAVNEOS After Identifying Efficacy Gaps Read Post »
Clinical TrialsOruka Therapeutics Reports Strong 16-Week Results for ORKA-001 in Psoriasis Oruka Therapeutics Reports Strong 16-Week Results for ORKA-001 in Psoriasis Read Post »
Health TidingsJohnson & Johnson Secures FDA Priority Review for IMAAVY® in wAIHA Johnson & Johnson Secures FDA Priority Review for IMAAVY® in wAIHA Read Post »
Health TidingsOncolytics Biotech Aligns with FDA on Pivotal Trial Design for Pelareorep i... Oncolytics Biotech Aligns with FDA on Pivotal Trial Design for Pelareorep i... Read Post »
New Drug ApprovalNovartis Targets the Root of CSU With EU Approval of Rhapsido Novartis Targets the Root of CSU With EU Approval of Rhapsido Read Post »
Clinical TrialsIntellia Backs Lonvo-z as One-Time CRISPR Therapy for HAE in Phase 3 HAELO Intellia Backs Lonvo-z as One-Time CRISPR Therapy for HAE in Phase 3 HAELO Read Post »
Health TidingsGSK moves efimosfermin forward with dual US FDA Breakthrough and EMA PRIME ... GSK moves efimosfermin forward with dual US FDA Breakthrough and EMA PRIME ... Read Post »
Health TidingsJazz Marks FDA Acceptance, Priority Review Milestone for Zanidatamab Jazz Marks FDA Acceptance, Priority Review Milestone for Zanidatamab Read Post »
New Drug ApprovalJohnson & Johnson Gains FDA Nod for CAPLYTA in Schizophrenia Johnson & Johnson Gains FDA Nod for CAPLYTA in Schizophrenia Read Post »
Health TidingsAbbVie Steps Beyond Infusion with SC SKYRIZI Filing in Crohn’s Disease AbbVie Steps Beyond Infusion with SC SKYRIZI Filing in Crohn’s Disease Read Post »
Health Tidings Mergers & AcquisitionsBioMarin Bolsters Its Rare Disease Portfolio Through Amicus Acquisition BioMarin Bolsters Its Rare Disease Portfolio Through Amicus Acquisition Read Post »
Health TidingsGSK stands firm on Jemperli as AnaptysBio seeks to reclaim rights GSK stands firm on Jemperli as AnaptysBio seeks to reclaim rights Read Post »
Mergers & AcquisitionsEli Lilly Bets Big on Next-Gen JAK2 Science with Ajax Therapeutics Deal Eli Lilly Bets Big on Next-Gen JAK2 Science with Ajax Therapeutics Deal Read Post »
New Drug ApprovalAstraZeneca Clinches FDA Approval for Saphnelo Autoinjector in SLE AstraZeneca Clinches FDA Approval for Saphnelo Autoinjector in SLE Read Post »
Clinical TrialsZydus Takes Zintrodiazine to Phase III After DCGI Clearance in India Zydus Takes Zintrodiazine to Phase III After DCGI Clearance in India Read Post »
GenericsAlembic Secures USFDA Approval for Fingolimod capsules for MS Alembic Secures USFDA Approval for Fingolimod capsules for MS Read Post »
Health Tidings Mergers & AcquisitionsSun Pharma Acquires Organon in $11.75 Billion Deal Sun Pharma Acquires Organon in $11.75 Billion Deal Read Post »
