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4759 News Found

Alembic Pharmaceuticals receives EIR from USFDA for oncology formulation facility
Drug Approval | May 07, 2024

Alembic Pharmaceuticals receives EIR from USFDA for oncology formulation facility

With this, for all our USFDA facilities, EIRs are in place


Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals
Drug Approval | May 06, 2024

Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals

Eugia Pharma Specialities receives 7 observations from USFDA for Unit II


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


AstraZeneca’s Truqap plus Faslodex recommended for approval in the EU by CHMP for cancer treatment
Drug Approval | April 29, 2024

AstraZeneca’s Truqap plus Faslodex recommended for approval in the EU by CHMP for cancer treatment

Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50%


Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal
Drug Approval | April 28, 2024

Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal

The USFDA has issued 5 observations pursuant to the completion of audit


Bafna Pharmaceuticals inaugurates Quality Control Lab
News | April 28, 2024

Bafna Pharmaceuticals inaugurates Quality Control Lab

The QC Lab is equipped with advanced instruments to ensure rigorous quality control across all manufacturing processes


Dr. Reddy's and Nestle India to form JV for health science nutraceutical portfolio
News | April 26, 2024

Dr. Reddy's and Nestle India to form JV for health science nutraceutical portfolio

The joint venture will help JV Partners combine their strengths and grow their complementary nutraceuticals portfolios


Voydeya approved in the EU as add-on treatment to ravulizumab
News | April 23, 2024

Voydeya approved in the EU as add-on treatment to ravulizumab

ALPHA Phase III trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris improved haemoglobin levels and reduced anaemia and fatigue


Kwality Pharmaceuticals receives approval from INVIMA for Ampoule and Vial product lines
Drug Approval | April 23, 2024

Kwality Pharmaceuticals receives approval from INVIMA for Ampoule and Vial product lines

Approval from Colombia's INVIMA will accelerate growth in Colombia, by registering our product and getting regular supplies


Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA
Drug Approval | April 22, 2024

Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA

NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A