Clinical TrailsJohnson & 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 TrailsAbbVie 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 TrailsTeva’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 TrailsTanabe 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 TrailsPhase 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 Removes Suicidal Ideation Warning From GLP-1 Weight-Loss Drugs FDA Removes Suicidal Ideation Warning From GLP-1 Weight-Loss Drugs Read Post »
Clinical TrailsBristol 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 TrailsJohnson & 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 TrailsBepirovirsen Shows Phase III Success in Chronic Hepatitis B, GSK Confirms Bepirovirsen Shows Phase III Success in Chronic Hepatitis B, GSK Confirms Read Post »
Clinical TrailsLilly’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 TrailsJohnson & 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 »
Clinical TrailsFull Phase 3 TULIP-SC Results Support Self-Administered Saphnelo for Lupus Full Phase 3 TULIP-SC Results Support Self-Administered Saphnelo for Lupus Read Post »
New Drug ApprovalHealth Canada Approves REDEMPLO (plozasiran) for Familial Chylomicronemia S... Health Canada Approves REDEMPLO (plozasiran) for Familial Chylomicronemia S... Read Post »
Health Tidings ResearchAbbott Launches Libre Assist in Libre App to Improve In-the-Moment Food Dec... Abbott Launches Libre Assist in Libre App to Improve In-the-Moment Food Dec... Read Post »
New Drug ApprovalModerna Files With FDA, EMA, Health Canada and TGA for New mRNA Flu Shot Moderna Files With FDA, EMA, Health Canada and TGA for New mRNA Flu Shot Read Post »
New Drug ApprovalAltimmune’s Pemvidutide Granted FDA Breakthrough Therapy Designation for ... Altimmune’s Pemvidutide Granted FDA Breakthrough Therapy Designation for ... Read Post »
New Drug ApprovalGSK’s Nucala (Mepolizumab) Gains China NMPA Approval for Eosinophilic... GSK’s Nucala (Mepolizumab) Gains China NMPA Approval for Eosinophilic... Read Post »
New Drug ApprovalSanofi’s Tzield (Teplizumab) Gains FDA Priority Review for 1-Year-Old... Sanofi’s Tzield (Teplizumab) Gains FDA Priority Review for 1-Year-Old... Read Post »
New Drug ApprovalMHRA Approves Kostaive (Zapomeran) sa-mRNA COVID Booster for UK Adults-Key ... MHRA Approves Kostaive (Zapomeran) sa-mRNA COVID Booster for UK Adults-Key ... Read Post »
New Drug ApprovalUltragenyx Completes Rolling BLA for First-in-Class DTX401 Gene Therapy in ... Ultragenyx Completes Rolling BLA for First-in-Class DTX401 Gene Therapy in ... Read Post »
ResearchPolyrizon Submits Pre-Request for Designation to FDA for PL-16 Viral Blocke... Polyrizon Submits Pre-Request for Designation to FDA for PL-16 Viral Blocke... Read Post »
Drugs Safety Alert ResearchNimesulide’s Rise and Reckoning in India: Ending with a Nationwide Ban on... Nimesulide’s Rise and Reckoning in India: Ending with a Nationwide Ban on... Read Post »
Drugs Safety AlertFDA Adds New Safety Warning to ALTUVIIIO Label FDA Adds New Safety Warning to ALTUVIIIO Label Read Post »
New Drug ApprovalFDA Accepts Axsome’s AXS-05 Supplemental NDA and Grants Priority Review f... FDA Accepts Axsome’s AXS-05 Supplemental NDA and Grants Priority Review f... Read Post »
Health Tidings ResearchFDA Issues Third CRL for Outlook Therapeutics’ ONS-5010/LYTENAVA in W... FDA Issues Third CRL for Outlook Therapeutics’ ONS-5010/LYTENAVA in W... Read Post »
Drugs Safety Alert ResearchSemaglutide and Eye Health: A Look at NAION Risk Semaglutide and Eye Health: A Look at NAION Risk Read Post »
Health Tidings ResearchCorcept Therapeutics Receives FDA Complete Response Letter for Relacorilant... Corcept Therapeutics Receives FDA Complete Response Letter for Relacorilant... Read Post »
New Drug ApprovalFDA Clears NEREUS, First New Motion Sickness Drug in Decades FDA Clears NEREUS, First New Motion Sickness Drug in Decades Read Post »
