Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 155

Results For "NDA"

3673 News Found

Shilpa Pharma Lifesciences’ Unit II, Raichur, Karnataka clears PMDA Japan, GMP inspection
Drug Approval | September 02, 2023

Shilpa Pharma Lifesciences’ Unit II, Raichur, Karnataka clears PMDA Japan, GMP inspection

The inspection has concluded successfully on 1st September 2023 without any critical/major observation


Sanofi announces changes to its Executive Committee
People | September 01, 2023

Sanofi announces changes to its Executive Committee

Brian Foard will lead the Specialty Care GBU ad interim, effective immediately.


USFDA approves BMS’ Reblozyl as first-line treatment of anemia in adults with Myelodysplastic Syndromes
Drug Approval | September 01, 2023

USFDA approves BMS’ Reblozyl as first-line treatment of anemia in adults with Myelodysplastic Syndromes

Reblozyl is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia


Pfizer and BioNTech receive positive CHMP opinion for Omicron XBB.1.5-adapted COVID-19 vaccine
News | September 01, 2023

Pfizer and BioNTech receive positive CHMP opinion for Omicron XBB.1.5-adapted COVID-19 vaccine

The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5 sublineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older


Strides receives USFDA approval for Mycophenolate Mofetil for oral suspension
Drug Approval | August 31, 2023

Strides receives USFDA approval for Mycophenolate Mofetil for oral suspension

The approval bolsters the company's Mycophenolate Mofetil portfolio


Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules
Drug Approval | August 31, 2023

Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules

Topiramate is the generic version of Supernus Pharmaceuticals’ Trokendi XR


Mankind Pharma launches 120 premium DMF quality drugs for Indian Patients
News | August 30, 2023

Mankind Pharma launches 120 premium DMF quality drugs for Indian Patients

Mankind Pharma's initiative aims to ensure universal access to medicines of international calibre


European Commission approves Keytruda plus Trastuzumab and chemotherapy as first-line treatment for GEJ
Drug Approval | August 30, 2023

European Commission approves Keytruda plus Trastuzumab and chemotherapy as first-line treatment for GEJ

KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population


CK Birla Hospital signs MoU Intuitive for robotic-assisted surgery
Medical Device | August 30, 2023

CK Birla Hospital signs MoU Intuitive for robotic-assisted surgery

Hospital joins with Intuitive to install da Vinci systems to support enhanced healthcare delivery and patient outcomes across India


BlueRock’s Phase I study with bemdaneprocel in patients with Parkinson’s disease meets primary endpoint
Diagnostic Center | August 29, 2023

BlueRock’s Phase I study with bemdaneprocel in patients with Parkinson’s disease meets primary endpoint

Investigational cellular therapy, bemdaneprocel (BRT-DA01), was well tolerated with no major safety issues in all 12 participants in low dose and high dose cohorts through one year / At one-year