Clinical TrialsInnovent Reports Positive Phase 3 Data for IBI302 in Wet AMD Innovent Reports Positive Phase 3 Data for IBI302 in Wet AMD Read Post »
Clinical TrialsSarepta Advances siRNA Pipeline with Early FSHD and DM1 Trial Data Sarepta Advances siRNA Pipeline with Early FSHD and DM1 Trial Data 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 »
Clinical TrialsNovo Nordisk, TUL Report Positive UBT251 Phase 2 Results Novo Nordisk, TUL Report Positive UBT251 Phase 2 Results 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 »
Clinical TrialsOcugen’s OCU410 Demonstrates 31% Lesion Reduction in Phase 2 GA Trial Ocugen’s OCU410 Demonstrates 31% Lesion Reduction in Phase 2 GA Trial 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 »
Drugs Safety AlertAardvark Halts ARD-101 and ARD-201 Studies After QRS Signal in Safety Study Aardvark Halts ARD-101 and ARD-201 Studies After QRS Signal in Safety Study Read Post »
New Drug ApprovalJapan Approves Dupixent for Adults with Bullous Pemphigoid Japan Approves Dupixent for Adults with Bullous Pemphigoid Read Post »
New Drug ApprovalPharming’s Joenja Approved in Japan as First Treatment for APDS Pharming’s Joenja Approved in Japan as First Treatment for APDS 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 »
Clinical TrialsDizal Reports Positive Phase 3 Sunvozertinib Results in NSCLC Dizal Reports Positive Phase 3 Sunvozertinib Results in NSCLC Read Post »
Mergers & Acquisitions Policy & AcquisitionsGilead to Acquire Ouro Medicines for $1.7B; Galapagos in Talks to Partner o... Gilead to Acquire Ouro Medicines for $1.7B; Galapagos in Talks to Partner o... Read Post »
Drugs Safety AlertSeizure Risk Tied to Vitamin B6 Deficiency Prompts FDA Label Changes for Pa... Seizure Risk Tied to Vitamin B6 Deficiency Prompts FDA Label Changes for Pa... Read Post »
Lifestyle WellnessGalderma Secures FDA Approval for Restylane Contour in Temple Hollowing Galderma Secures FDA Approval for Restylane Contour in Temple Hollowing 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 »
Clinical TrialsApogee’s Zumilokibart Delivers 52-Week Control in Atopic Dermatitis Trial Apogee’s Zumilokibart Delivers 52-Week Control in Atopic Dermatitis Trial Read Post »
Mergers & AcquisitionsSanofi Inks Up to $1.23B Licensing Deal for Kali Therapeutics’ Autoimmune... Sanofi Inks Up to $1.23B Licensing Deal for Kali Therapeutics’ Autoimmune... Read Post »
Clinical TrialsFDA Grants Priority Review to Ionis’ Zilganersen for Rare Alexander Disea... FDA Grants Priority Review to Ionis’ Zilganersen for Rare Alexander Disea... 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 »
Clinical TrialsInsmed’s ARIKAYCE Hits Key Endpoints in Phase 3b ENCORE Trial Insmed’s ARIKAYCE Hits Key Endpoints in Phase 3b ENCORE Trial 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 »
Clinical TrialsPfizer and Valneva Report >70% Efficacy for Lyme Vaccine Candidate in Phase... Pfizer and Valneva Report >70% Efficacy for Lyme Vaccine Candidate in Phase... 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 »
Clinical TrialsRoche Stops Emugrobart in SMA and FSHD Trials After Weak Functional Outcome... Roche Stops Emugrobart in SMA and FSHD Trials After Weak Functional Outcome... 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 »
Clinical TrialsBiohaven Completes Enrollment in Phase 2 Trial of Taldefgrobep for Obesity Biohaven Completes Enrollment in Phase 2 Trial of Taldefgrobep for Obesity Read Post »
WellnessShionogi Launches ZURZUVAE (Zuranolone) in Japan for Major Depressive Disor... Shionogi Launches ZURZUVAE (Zuranolone) in Japan for Major Depressive Disor... 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 »
Clinical TrialsBiogen-Eisai’s LEQEMBI Shows Strong Real-World Treatment Persistence ... Biogen-Eisai’s LEQEMBI Shows Strong Real-World Treatment Persistence ... Read Post »
Clinical TrialsSerum Institute Taps Eveliqure Platform for Anti-Diarrhoeal Vaccines in Chi... Serum Institute Taps Eveliqure Platform for Anti-Diarrhoeal Vaccines in Chi... 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 »
New Drug ApprovalNivolumab Plus AVD Approved by FDA as Frontline Therapy for Advanced cHL Nivolumab Plus AVD Approved by FDA as Frontline Therapy for Advanced cHL 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 »
New Drug ApprovalFDA Approves IMCIVREE as First Therapy for Acquired Hypothalamic Obesity FDA Approves IMCIVREE as First Therapy for Acquired Hypothalamic Obesity 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 »
Clinical TrialsChugai Files in Japan for Ocular Implant Component of Ranibizumab Port Deli... Chugai Files in Japan for Ocular Implant Component of Ranibizumab Port Deli... 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 »
Lifestyle WellnessCortisol Detox: Can You Really Reset Your Stress Hormones? Cortisol Detox: Can You Really Reset Your Stress Hormones? Read Post »
New Drug ApprovalWegovy HD Approved by FDA After Trials Show ~21% Weight Loss Wegovy HD Approved by FDA After Trials Show ~21% Weight Loss 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 »
