Health TidingsAfter FDA Approval, J&J Shows Durable 52-Week ICOTYDE Results in Psoria... After FDA Approval, J&J Shows Durable 52-Week ICOTYDE Results in Psoria... Read Post »
Health TidingsPriovant’s Brepocitinib Gains Priority Review After Phase 3 Success Priovant’s Brepocitinib Gains Priority Review After Phase 3 Success Read Post »
Health TidingsNovartis’ Fabhalta Cuts Kidney Function Decline by 50% in Phase 3 Novartis’ Fabhalta Cuts Kidney Function Decline by 50% in Phase 3 Read Post »
Health TidingsBIMZELX Shows Durable Remission in Psoriasis and Sustained 3-Year Control i... BIMZELX Shows Durable Remission in Psoriasis and Sustained 3-Year Control i... Read Post »
Health TidingsOrganon Highlights Week 1 Improvements with VTAMA in Atopic Dermatitis Organon Highlights Week 1 Improvements with VTAMA in Atopic Dermatitis Read Post »
Health TidingsFDA Clears Lantern–Starlight STAR-001 Study in Pediatric Brain Cancer FDA Clears Lantern–Starlight STAR-001 Study in Pediatric Brain Cancer Read Post »
Health TidingsOtsuka Seeks Japan Approval for First-Line Use of Iclusig in Ph+ ALL Otsuka Seeks Japan Approval for First-Line Use of Iclusig in Ph+ ALL Read Post »
Health TidingsGSK’s Bepirovirsen Accepted by EMA for Review in Chronic Hepatitis B GSK’s Bepirovirsen Accepted by EMA for Review in Chronic Hepatitis B Read Post »
Health Tidings Mergers & AcquisitionsBiogen Signs Deal with Alteogen to Develop Subcutaneous Versions of Two Bio... Biogen Signs Deal with Alteogen to Develop Subcutaneous Versions of Two Bio... Read Post »
GenericsNovo Nordisk Sues Dr. Reddy’s Over “Olymviq” Name, Says It Too Closel... Novo Nordisk Sues Dr. Reddy’s Over “Olymviq” Name, Says It Too Closel... Read Post »
Health TidingsOno Submits Ripretinib for Approval in Japan to Treat Advanced Gastrointest... Ono Submits Ripretinib for Approval in Japan to Treat Advanced Gastrointest... Read Post »
Medical DevicesNovocure Reports Encouraging Phase 2 Data for TTFields in Pancreatic Cancer Novocure Reports Encouraging Phase 2 Data for TTFields in Pancreatic Cancer Read Post »
ManufacturingIonis Cuts TRYNGOLZA Price Ahead of Potential sHTG Approval Ionis Cuts TRYNGOLZA Price Ahead of Potential sHTG Approval Read Post »
CRO Medical DevicesTerumo, Tata Elxsi Open Offshore Center for Cardiovascular Innovation Terumo, Tata Elxsi Open Offshore Center for Cardiovascular Innovation Read Post »
Health Tidings Mergers & AcquisitionsMerck to Buy Terns, Strengthening CML Pipeline with TERN-701 Merck to Buy Terns, Strengthening CML Pipeline with TERN-701 Read Post »
Health Tidings Mergers & AcquisitionsAlnylam, Viz.ai Partner to Advance AI Detection of ATTR-CM Alnylam, Viz.ai Partner to Advance AI Detection of ATTR-CM Read Post »
Health TidingsFDA Warns ImmunityBio Over Misleading Promotion of Cancer Drug ANKTIVA FDA Warns ImmunityBio Over Misleading Promotion of Cancer Drug ANKTIVA Read Post »
GenericsLupin’s Pitolisant Tablets Get Tentative FDA Approval as Generic Wakix Lupin’s Pitolisant Tablets Get Tentative FDA Approval as Generic Wakix Read Post »
Health TidingsEnlivex’s Allocetra™ IND Cleared by FDA to Enter Phase 2b Trial for Kne... Enlivex’s Allocetra™ IND Cleared by FDA to Enter Phase 2b Trial for Kne... Read Post »
GenericsSandoz Launches Azelastine/Fluticasone Combination Nasal Spray in Germany a... Sandoz Launches Azelastine/Fluticasone Combination Nasal Spray in Germany a... Read Post »
Generics New Drug ApprovalViatris’ Effexor SR Becomes First Approved Treatment for Generalized Anxi... Viatris’ Effexor SR Becomes First Approved Treatment for Generalized Anxi... Read Post »
Health TidingsEvotec’s Just – Evotec Biologics Wins BARDA BioMaP Contract for Ebola a... Evotec’s Just – Evotec Biologics Wins BARDA BioMaP Contract for Ebola a... Read Post »
Health TidingsGSK’s B7-H3 ADC Ris-Rez Wins Orphan Drug Status in Japan for SCLC GSK’s B7-H3 ADC Ris-Rez Wins Orphan Drug Status in Japan for SCLC Read Post »
Health TidingsEMA Accepts Astellas Application for PADCEV–Keytruda Combo in Neoadjuvant... EMA Accepts Astellas Application for PADCEV–Keytruda Combo in Neoadjuvant... Read Post »
GenericsIndia’s Semaglutide Generic Boom: The Race for Market Dominance Follo... India’s Semaglutide Generic Boom: The Race for Market Dominance Follo... Read Post »
GenericsNATCO Rolls Out Affordable Generic Semaglutide for Type 2 Diabetes in India NATCO Rolls Out Affordable Generic Semaglutide for Type 2 Diabetes in India Read Post »
Health TidingsVanda Says FDA Draft on New Approach Methodologies Lacks Clarity Vanda Says FDA Draft on New Approach Methodologies Lacks Clarity Read Post »
Health Tidings Policy & AcquisitionsOxford, Serum Institute Partner to Advance ChAdOx1 Nipah Vaccine Oxford, Serum Institute Partner to Advance ChAdOx1 Nipah Vaccine Read Post »
Health TidingsMHRA and NICE Launch Aligned Pathway to Speed Access to New Medicines MHRA and NICE Launch Aligned Pathway to Speed Access to New Medicines Read Post »
Health TidingsGalimedix Reports Improved PK Profile for Next-Generation Oral Aβ Modulato... Galimedix Reports Improved PK Profile for Next-Generation Oral Aβ Modulato... Read Post »
Health Tidings Policy & AcquisitionsNovartis Targets PIK3CA-Mutant Tumors With $3B Synnovation Deal for SNV4818 Novartis Targets PIK3CA-Mutant Tumors With $3B Synnovation Deal for SNV4818 Read Post »
Health TidingsCARDAMYST™ Nasal Spray Off to a Strong Start in the U.S., Milestone Repor... CARDAMYST™ Nasal Spray Off to a Strong Start in the U.S., Milestone Repor... Read Post »
GenericsGlenmark Launches Milnacipran an Authorized Generic of Savella in the U.S.,... Glenmark Launches Milnacipran an Authorized Generic of Savella in the U.S.,... Read Post »
Health TidingsNew Biotech Kalohexis Targets Metabolic ‘Thermostat’ to Treat Obesity a... New Biotech Kalohexis Targets Metabolic ‘Thermostat’ to Treat Obesity a... Read Post »
Health TidingsEvotec–BMS Molecular Glue Candidate BMS-986506 Enters Phase 1 Trial Evotec–BMS Molecular Glue Candidate BMS-986506 Enters Phase 1 Trial Read Post »
Health Tidings Policy & AcquisitionsWhat Is FDA’s New Approach Methodologies (NAMs) Framework for Non-Animal ... What Is FDA’s New Approach Methodologies (NAMs) Framework for Non-Animal ... Read Post »
Health TidingsSarepta Plans sNDA Submissions for Full Approval of DMD Therapies AMONDYS 4... Sarepta Plans sNDA Submissions for Full Approval of DMD Therapies AMONDYS 4... Read Post »
Health TidingsLilly’s Retatrutide Shows Up to 2.0% A1C Reduction and 16.8% Weight Loss ... Lilly’s Retatrutide Shows Up to 2.0% A1C Reduction and 16.8% Weight Loss ... Read Post »
Health TidingsPriavoid Reports Low ARIA Rates for Oral Alzheimer’s Drug PRI-002 Priavoid Reports Low ARIA Rates for Oral Alzheimer’s Drug PRI-002 Read Post »
Health TidingsCSL Works to Restore Hemgenix Supply Amid Temporary Global Stockout CSL Works to Restore Hemgenix Supply Amid Temporary Global Stockout Read Post »
Health TidingsSanofi Receives U.S. FDA Breakthrough Therapy Designation for Venglustat fo... Sanofi Receives U.S. FDA Breakthrough Therapy Designation for Venglustat fo... Read Post »
GenericsZydus Expands Semaglutide Reach in India Through Co-Marketing Deals with To... Zydus Expands Semaglutide Reach in India Through Co-Marketing Deals with To... Read Post »
Health TidingsIllumina, Veritas Team Up to Integrate Preventive Genomics in Healthcare Illumina, Veritas Team Up to Integrate Preventive Genomics in Healthcare Read Post »
Health TidingsChina Speeds Review of Gyre’s Hydronidone China Speeds Review of Gyre’s Hydronidone Read Post »
Health TidingsSarepta Initiates New ENDEAVOR Cohort to Reduce ELEVIDYS Liver Toxicity Ris... Sarepta Initiates New ENDEAVOR Cohort to Reduce ELEVIDYS Liver Toxicity Ris... Read Post »
Health TidingsAldeyra Receives FDA Complete Response Letter for Reproxalap, Citing Lack o... Aldeyra Receives FDA Complete Response Letter for Reproxalap, Citing Lack o... Read Post »
Health Tidings Policy & AcquisitionsZydus’ Sentynl Licenses Progerinin from PRG S&T to Advance Rare Disea... Zydus’ Sentynl Licenses Progerinin from PRG S&T to Advance Rare Disea... Read Post »
Health TidingsSun Pharma’s ILUMYA sBLA Accepted by FDA for Psoriatic Arthritis Sun Pharma’s ILUMYA sBLA Accepted by FDA for Psoriatic Arthritis Read Post »
Health TidingsLilly Expands Affordable Access to Zepbound KwikPen for Weight Management Lilly Expands Affordable Access to Zepbound KwikPen for Weight Management Read Post »
Health Tidings Policy & AcquisitionsSamsung Bioepis Partners with G2GBIO to Develop Long-Acting Semaglutide Usi... Samsung Bioepis Partners with G2GBIO to Develop Long-Acting Semaglutide Usi... Read Post »
