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594 News Found

Pfizer and BioNTech receive Positive CHMP opinion for Omicron JN.1-adapted COVID-19 vaccine in EU
News | June 28, 2024

Pfizer and BioNTech receive Positive CHMP opinion for Omicron JN.1-adapted COVID-19 vaccine in EU

Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission


Bristol Myers Squibb receives USFDA accelerated approval of Krazati in combination with Cetuximab for CRC
Drug Approval | June 22, 2024

Bristol Myers Squibb receives USFDA accelerated approval of Krazati in combination with Cetuximab for CRC

Second FDA approval for KRAZATI - reinforcing its potential across tumor types


USFDA approves next-gen TKI Augtyro for treatment of solid tumors
Drug Approval | June 17, 2024

USFDA approves next-gen TKI Augtyro for treatment of solid tumors

Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors


Moderna receives U.S. FDA approval for RSV Vaccine mRESVIA
Drug Approval | June 01, 2024

Moderna receives U.S. FDA approval for RSV Vaccine mRESVIA

mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes


BlueRock Therapeutics receives FDA RMAT designation for Parkinson’s disease cell therapy candidate bemdaneprocel
Drug Approval | May 31, 2024

BlueRock Therapeutics receives FDA RMAT designation for Parkinson’s disease cell therapy candidate bemdaneprocel

Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.S. for treating patients living with Parkinson’s disease


FDA grants priority review to Merck’s application for Keytruda plus chemotherapy for metastatic malignant pleural mesothelioma
Drug Approval | May 30, 2024

FDA grants priority review to Merck’s application for Keytruda plus chemotherapy for metastatic malignant pleural mesothelioma

Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients


Indica Labs receives FDA clearance for HALO AP Dx digital pathology platform
Digitisation | May 23, 2024

Indica Labs receives FDA clearance for HALO AP Dx digital pathology platform

For use with Hamamatsu Images acquired with the NanoZoomer S360MD slide scanner


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


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


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