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1408 News Found

Biocon Biologics’ receives FDA approval for Biosimilar Aflibercept for Yesafili
Drug Approval | May 21, 2024

Biocon Biologics’ receives FDA approval for Biosimilar Aflibercept for Yesafili

The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States


Dupixent late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM
Clinical Trials | May 21, 2024

Dupixent late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM

Data support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted therapy for COPD


Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi approved by USFDA
Clinical Trials | May 20, 2024

Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi approved by USFDA

95.7% of patients responded to Breyanzi in the TRANSCEND FL trial


Arvinas and Pfizer announce updated clinical data from Phase 1b Trial of Vepdegestrant in combination with Palbociclib
Clinical Trials | May 18, 2024

Arvinas and Pfizer announce updated clinical data from Phase 1b Trial of Vepdegestrant in combination with Palbociclib

At the recommended Phase 3 dose of 200 mg vepdegestrant in combination with palbociclib, patients achieved a median progression-free survival of 13.9 months


Elinzanetant significantly reduces frequency and severity of hot flashes associated with menopause
Clinical Trials | May 17, 2024

Elinzanetant significantly reduces frequency and severity of hot flashes associated with menopause

Pivotal OASIS 1 and 2 Phase III studies of investigational compound elinzanetant achieved a statistically significant reduction in frequency and severity of vasomotor symptoms


Bayer starts Phase I study with novel targeted radionuclide therapy in advanced metastatic prostate cancer
Clinical Trials | May 16, 2024

Bayer starts Phase I study with novel targeted radionuclide therapy in advanced metastatic prostate cancer

225Ac-PSMA-Trillium is an investigational next-generation PSMA-targeted alpha therapy with potential to treat patients with advanced metastatic prostate cancer


Moderna update on investigational RSV vaccine
Drug Approval | May 14, 2024

Moderna update on investigational RSV vaccine

U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024


AstraZeneca’s Calquence combination regimen demonstrated positive results in 1st-line mantle cell lymphoma in ECHO Phase III trial
Clinical Trials | May 08, 2024

AstraZeneca’s Calquence combination regimen demonstrated positive results in 1st-line mantle cell lymphoma in ECHO Phase III trial

First BTK inhibitor to show favourable trend in overall survival vs. standard-of-care chemoimmunotherapy in this setting


Moderna posts Q1 2024 revenues at US$167 million
News | May 03, 2024

Moderna posts Q1 2024 revenues at US$167 million

GAAP net loss of $1.2 billion and GAAP diluted EPS of $(3.07)


Merck announces positive data for investigational, 21-Valent pneumococcal conjugate vaccine
Clinical Trials | May 02, 2024

Merck announces positive data for investigational, 21-Valent pneumococcal conjugate vaccine

Late-breaker Phase 3 STRIDE-10 trial presented as an oral presentation at European Society of Clinical Microbiology and Infectious Diseases