Clinical TrialsSanofi’s Amlitelimab Strengthens Phase 3 Evidence in Atopic Dermatitis wi... Sanofi’s Amlitelimab Strengthens Phase 3 Evidence in Atopic Dermatitis wi... Read Post »
New Drug ApprovalSun Pharma Wins DCGI Approval for Noveltreat, Generic Semaglutide Injection... Sun Pharma Wins DCGI Approval for Noveltreat, Generic Semaglutide Injection... Read Post »
New Drug ApprovalGSK’s Trelegy Ellipta Approved by NMPA in China for Adult Asthma GSK’s Trelegy Ellipta Approved by NMPA in China for Adult Asthma Read Post »
Clinical TrialsCorcept Reports Overall Survival Benefit with Relacorilant in Platinum-Resi... Corcept Reports Overall Survival Benefit with Relacorilant in Platinum-Resi... Read Post »
Clinical TrialsBayer and BlueRock’s OpCT-001 Receives FDA Orphan Drug Designation for Re... Bayer and BlueRock’s OpCT-001 Receives FDA Orphan Drug Designation for Re... Read Post »
Clinical TrialsImmunityBio Advances ANKTIVA Toward FDA Resubmission in Papillary NMIBC ImmunityBio Advances ANKTIVA Toward FDA Resubmission in Papillary NMIBC Read Post »
Clinical TrialsFDA Grants Fast Track Designation to BioNTech’s BNT113 for HPV16-Positive... FDA Grants Fast Track Designation to BioNTech’s BNT113 for HPV16-Positive... Read Post »
Clinical TrialsFDA Grants Breakthrough Therapy Designation to Lilly’s Sofetabart Mipitec... FDA Grants Breakthrough Therapy Designation to Lilly’s Sofetabart Mipitec... Read Post »
Clinical TrialsModerna–Merck mRNA Cancer Vaccine Combo Shows Durable Five-Year Recurrenc... Moderna–Merck mRNA Cancer Vaccine Combo Shows Durable Five-Year Recurrenc... Read Post »
Drugs Safety AlertOrganon’s NEXPLANON Now Approved for Up to Five Years of Contraception wi... Organon’s NEXPLANON Now Approved for Up to Five Years of Contraception wi... Read Post »
New Drug ApprovalEMA Validates ENHERTU Plus Pertuzumab for First-Line HER2 Positive Metastat... EMA Validates ENHERTU Plus Pertuzumab for First-Line HER2 Positive Metastat... Read Post »
Clinical TrialsSimcere and Lynk Report Positive Phase III Data for Zemprocitinib in Modera... Simcere and Lynk Report Positive Phase III Data for Zemprocitinib in Modera... Read Post »
New Drug ApprovalNMPA Review Begins for Envafolimab NDA in Biliary Cancer NMPA Review Begins for Envafolimab NDA in Biliary Cancer Read Post »
Drugs Safety Alert Health TidingsFDA Issues Warning Letter to Telangana’s Palamur Biosciences Over GLP Ris... FDA Issues Warning Letter to Telangana’s Palamur Biosciences Over GLP Ris... Read Post »
Lifestyle Research WellnessSmall Steps, Longer Lives: Lancet Study Links Minutes of Movement to Lower ... Small Steps, Longer Lives: Lancet Study Links Minutes of Movement to Lower ... Read Post »
New Drug ApprovalEU Approves Eylea 8 mg for Retinal Vein Occlusion After Durable Results in ... EU Approves Eylea 8 mg for Retinal Vein Occlusion After Durable Results in ... Read Post »
Clinical TrialsAxsome Therapeutics Doses First Patient in Phase 3 FORWARD Trial of AXS-14 ... Axsome Therapeutics Doses First Patient in Phase 3 FORWARD Trial of AXS-14 ... Read Post »
Clinical TrialsJohnson & Johnson Presents New Evidence That CAPLYTA With Antidepressan... Johnson & Johnson Presents New Evidence That CAPLYTA With Antidepressan... Read Post »
New Drug ApprovalAtossa Therapeutics Secures FDA Orphan Drug Designation for (Z)-Endoxifen i... Atossa Therapeutics Secures FDA Orphan Drug Designation for (Z)-Endoxifen i... Read Post »
New Drug ApprovalNovartis’ Ianalumab Secures FDA Breakthrough Therapy Designation for Sjö... Novartis’ Ianalumab Secures FDA Breakthrough Therapy Designation for Sjö... Read Post »
Clinical TrialsAbbVie and Genmab Report Phase 3 Results for Epcoritamab in Relapsed DLBCL AbbVie and Genmab Report Phase 3 Results for Epcoritamab in Relapsed DLBCL Read Post »
Clinical TrialsTeva’s AJOVY Demonstrates Strong Efficacy in Reducing Pediatric Migraine ... Teva’s AJOVY Demonstrates Strong Efficacy in Reducing Pediatric Migraine ... Read Post »
New Drug ApprovalChina NMPA Approves Two Sanofi-Licensed Innovative Therapies: Myqorzo (Afic... China NMPA Approves Two Sanofi-Licensed Innovative Therapies: Myqorzo (Afic... Read Post »
ResearchINGREZZA Shows Nearly Double VMAT2 Target Occupancy Compared to AUSTEDO XR ... INGREZZA Shows Nearly Double VMAT2 Target Occupancy Compared to AUSTEDO XR ... Read Post »
Clinical TrialsTanabe Pharma Reports Positive Phase 3 INSPIRE Results for MT-7117 in EPP a... Tanabe Pharma Reports Positive Phase 3 INSPIRE Results for MT-7117 in EPP a... Read Post »
Clinical TrialsPhase 3 MajesTEC-9 Trial Shows TECVAYLI® Monotherapy Improves Survival in ... Phase 3 MajesTEC-9 Trial Shows TECVAYLI® Monotherapy Improves Survival in ... Read Post »
New Drug ApprovalAbbisko Therapeutics Achieves Major Milestone as FDA Accepts NDA for Pimico... Abbisko Therapeutics Achieves Major Milestone as FDA Accepts NDA for Pimico... Read Post »
New Drug ApprovalSebela Submits NDA for Tegoprazan as Potential First-in-Class P-CAB for GER... Sebela Submits NDA for Tegoprazan as Potential First-in-Class P-CAB for GER... Read Post »
Drugs Safety AlertFDA Reaffirms No Link Between GLP-1 Drugs and Suicidal Ideation; Supports L... FDA Reaffirms No Link Between GLP-1 Drugs and Suicidal Ideation; Supports L... Read Post »
Clinical TrialsBristol Myers Squibb Reports Positive Phase 3 SCOUT-HCM Results for Camzyos... Bristol Myers Squibb Reports Positive Phase 3 SCOUT-HCM Results for Camzyos... Read Post »
New Drug ApprovalBiogen’s High-Dose SPINRAZA Approved in EU Following DEVOTE Study Results Biogen’s High-Dose SPINRAZA Approved in EU Following DEVOTE Study Results Read Post »
New Drug ApprovalGSK Receives EU Approval for Ready-to-Use Prefilled Syringe Shingrix GSK Receives EU Approval for Ready-to-Use Prefilled Syringe Shingrix Read Post »
New Drug ApprovalFDA Accepts Camurus NDA Resubmission for Oclaiz™ in Acromegaly Treatment FDA Accepts Camurus NDA Resubmission for Oclaiz™ in Acromegaly Treatment Read Post »
New Drug ApprovalFDA Approves Zycubo (Copper Histidinate) Injection as First-Ever Treatment ... FDA Approves Zycubo (Copper Histidinate) Injection as First-Ever Treatment ... Read Post »
New Drug ApprovalFDA Grants Breakthrough Therapy Designation to Encoded Therapeutics’ ETX1... FDA Grants Breakthrough Therapy Designation to Encoded Therapeutics’ ETX1... Read Post »
Clinical TrialsJohnson & Johnson’s RYBREVANT® Shows Promising Long-Term Results in ... Johnson & Johnson’s RYBREVANT® Shows Promising Long-Term Results in ... Read Post »
New Drug ApprovalSanofi’s Teizeild Approved in EU to Delay Stage 3 Type 1 Diabetes Onset i... Sanofi’s Teizeild Approved in EU to Delay Stage 3 Type 1 Diabetes Onset i... Read Post »
Drugs Safety AlertFDA CBER Flags Rare Febrile Seizure Risk Linked to Influenza Vaccines FDA CBER Flags Rare Febrile Seizure Risk Linked to Influenza Vaccines Read Post »
New Drug ApprovalBayer’s Sevabertinib Gets Fast-Track Status in U.S. and China for HER2-Mu... Bayer’s Sevabertinib Gets Fast-Track Status in U.S. and China for HER2-Mu... Read Post »
New Drug ApprovalChina Grants First-in-World Approval to BeOne Medicines’ Sonrotoclax ... China Grants First-in-World Approval to BeOne Medicines’ Sonrotoclax ... Read Post »
New Drug ApprovalMilestone’s Etripamil Nasal Spray Accepted for EMA Review in PSVT Milestone’s Etripamil Nasal Spray Accepted for EMA Review in PSVT Read Post »
Clinical TrialsBepirovirsen Shows Phase III Success in Chronic Hepatitis B, GSK Confirms Bepirovirsen Shows Phase III Success in Chronic Hepatitis B, GSK Confirms Read Post »
Clinical TrialsLilly’s Taltz Plus Zepbound Delivers Superior Outcomes in Phase 3b Psoria... Lilly’s Taltz Plus Zepbound Delivers Superior Outcomes in Phase 3b Psoria... Read Post »
New Drug ApprovalFDA expands Cablivi approval to pediatric patients aged 12 and older with a... FDA expands Cablivi approval to pediatric patients aged 12 and older with a... Read Post »
New Drug ApprovalTakeda and Protagonist Submit NDA to FDA for Rusfertide in Polycythemia Ver... Takeda and Protagonist Submit NDA to FDA for Rusfertide in Polycythemia Ver... Read Post »
New Drug ApprovalFDA Grants Priority Review to Vera Therapeutics’ Atacicept for IgA Nephro... FDA Grants Priority Review to Vera Therapeutics’ Atacicept for IgA Nephro... Read Post »
Clinical TrialsJohnson & Johnson Reports Positive Phase 2b JASMINE Trial Results for N... Johnson & Johnson Reports Positive Phase 2b JASMINE Trial Results for N... Read Post »
New Drug ApprovalJapan Approves Exdensur After U.S. and UK, Expanding Access for Severe Asth... Japan Approves Exdensur After U.S. and UK, Expanding Access for Severe Asth... Read Post »
New Drug ApprovalZai Lab’s AUGTYRO (repotrectinib) Receives NMPA Approval for NTRK-Positiv... Zai Lab’s AUGTYRO (repotrectinib) Receives NMPA Approval for NTRK-Positiv... Read Post »
New Drug ApprovalChina Accepts BLA for Subcutaneous LEQEMBI for Early Alzheimer’s China Accepts BLA for Subcutaneous LEQEMBI for Early Alzheimer’s Read Post »
