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BMS 1Q: Opdivo Sales Down 10%, Announces Restructuring Initiative
Pfizer’s BEQVEZ Approved by FDA for Treatment of Adults with Hemophilia B
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Breaking News
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Trials & Filings
FDA Approves Utility Therapeutics’ Pivya in UTIs
Clinical trial shows 62% of the 137 subjects achieved the composite response compared to 10% who received placebo.
04.25.24
Breaking News
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Drug Development
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Trials & Filings
Sanofi’s Rilzabrutinib Meets Primary Endpoint in ITP
Demonstrates significantly higher proportion of patients receiving rilzabrutinib achieved primary endpoint of durable platelet response versus placebo.
04.23.24
Breaking News
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Drug Development
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Trials & Filings
Genentech's Alecensa Approved in Early-Stage NSCLC
Phase III ALINA study demonstrates Alecensa reduced the risk of disease recurrence or death by 76%.
04.19.24
Drug Development
|
Trials & Filings
Genentech’s Columvi Meets Primary Endpoint in DLBCL
Phase III study demonstrated that people lived longer when treated with Columvi in combination with gemcitabine and oxaliplatin.
04.15.24
Breaking News
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Drug Development
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Trials & Filings
AdrenoMed’s Enibarcimab Fast Tracked for Septic Shock
Enibarcimab has the potential to become the first treatment addressing the under-lying pathophysiology of sepsis.
04.10.24
Breaking News
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Drug Development
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Trials & Filings
AstraZeneca, Daiichi Sankyo's Enhertu Approved in Solid Tumors
Becomes first tumor-agnostic approval of a HER2-directed therapy and ADC by the FDA.
04.08.24
Biologics, Proteins, Vaccines
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Breaking News
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Trials & Filings
ViiV Healthcare Receives FDA Approval for Dovato for Adolescents
Expanded indication marks the first time an oral, two-drug, single-tablet regimen is available for adolescents between 12 & 18 living with HIV.
04.08.24
Biologics, Proteins, Vaccines
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Breaking News
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Trials & Filings
BMS, 2seventy bio Win FDA Approval for Abecma in Multiple Myeloma
Expands Abecma’s indication, making it available in earlier lines of therapy.
04.05.24
Drug Development
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Trials & Filings
FDA Filings Roundup
Basilea's antibiotic ZEVTERA approved for three indications, Vanda Pharmaceuticals' Fanapt approved for acute Bipolar I Disorder.
Online Exclusives
04.04.24
Breaking News
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Drug Development
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Trials & Filings
Vanda Pharmaceuticals' Fanapt Approved for Acute Bipolar I Disorder
Significantly increases the commercial opportunity for Fanapt.
04.04.24
Breaking News
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Drug Development
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Trials & Filings
Basilea’s Antibiotic ZEVTERA Approved for Three Indications
Staphylococcus aureus bloodstream infections, acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.
04.04.24
Breaking News
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Industry News
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Trials & Filings
Fanapt Approved by FDA for Treatment of Bipolar I Disorder
Gives patients and service providers a new treatment option for managing bipolar I disorder.
04.03.24
Breaking News
|
Trials & Filings
Voydeya Approved as Add-on Therapy to Treat Extravascular Haemolysis in PNH
Results showed that Voydeya met the primary endpoint of change in haemoglobin from baseline to week 12 and all key secondary endpoints.
04.01.24
Breaking News
|
Trials & Filings
Gilead's Vemlidy Approved to Treat Chronic HBV Infection in Patients as Young as 6
The expanded indication was supported by data from a Phase 2 clinical trial.
04.01.24
Breaking News
|
Trials & Filings
AbbVie’s ELAHERE Granted Full Approval by FDA for Ovarian Cancer
Full approval was based on data from the confirmatory Phase 3 MIRASOL trial.
03.25.24
Breaking News
|
Trials & Filings
Idorsia’s TRYVIO Approved by FDA for the Treatment of Hypertension
Idorsia plans to make TRYVIO available to the millions of patients in the US who are not controlled on other drugs in the second half of 2024.
03.21.24
Breaking News
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Drug Development
|
Trials & Filings
Forge’s AAV Gene Therapy Granted Innovation Passport Designation in Krabbe Disease
FBX-101 was created for the treatment of patients with Krabbe disease, a rare neurodegenerative disease.
03.19.24
Breaking News
|
Drug Development
|
Trials & Filings
FDA Approves BeiGene's TEVIMBRA in Esophageal Cancer
Phase 3 trial showed prolonged the survival of patients who received prior systemic treatment compared to chemotherapy.
03.15.24
Breaking News
|
Drug Development
|
Trials & Filings
FDA Grants Accelerated Approval for BMS’ Breyanzi in CLL, SLL
Complete response rate associated with Breyanzi treatment was 20% with median duration of response 35.3 months.
03.15.24
Breaking News
|
Drug Development
|
Trials & Filings
Madrigal Wins Accelerated Approval for NASH Drug Rezdiffra
Becomes the first and only medication approved by the FDA for the treatment of nonalcoholic steatohepatitis.
03.15.24
Breaking News
BMS 1Q: Opdivo Sales Down 10%, Announces Restructuring Initiative
Pfizer’s BEQVEZ Approved by FDA for Treatment of Adults with Hemophilia B
Abzena Introduces Enhanced Bioassay Platform
Fujifilm & Predictive Oncology Tackle Protein Interference
Regeneron & Mammoth Partner on CRISPR Therapies
View Breaking News >
CURRENT ISSUE
April 2024
Anti-Counterfeiting Technology
Navigating Global CDMO Trends
Weight-loss Drug Packaging
Clinical Supply CDMOs
Industry Experts Weigh in on Oral Solid Dosage
Newsmakers Q&A: Almac Group
Economical Mobile Workstations for Lower-Grade Cleanrooms
Pharmaceutical Manufacturing Equipment & Trends
Insight Into Obesity-Related Clinical Research
Inflation Reduction Act and the Impact on Biosimilars
View More >