IPP Bureau
FDA nod to groundbreaking bladder cancer combo therapy for surgery patients
By IPP Bureau - November 24, 2025
Call it a major milestone in bladder cancer therapy that aims to provide a lifeline for patients who previously had limited options
Marksans Pharma Inc. receives USFDA approval for Loperamide Hydrochloride Tablets
By IPP Bureau - November 24, 2025
Loperamide Hydrochloride is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhoea
Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla
By IPP Bureau - November 24, 2025
The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia
Aptus Pharma enters into urology therapy segment
By IPP Bureau - November 24, 2025
The company will soon be launching a new portfolio of products in this segment
Lupin receives 7 observations from USFDA for Goa manufacturing facility
By IPP Bureau - November 24, 2025
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
NATCO Pharma receives 7 observations from USFDA for API unit at Manali
By IPP Bureau - November 24, 2025
Ind-Swift Laboratories receives certifications from Bureau Veritas
By IPP Bureau - November 24, 2025
These certifications reflect the company's continuous commitment to maintaining international standards of environmental sustainability as well as occupational health and safety
FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures
By IPP Bureau - November 24, 2025
Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels
FDA investigates fatal case linked to rare blood disorder drug Adzynma
By IPP Bureau - November 24, 2025
Adzynma, approved for both adults and children with cTTP, is a recombinant enzyme therapy designed to replace the deficient ADAMTS13 enzyme
Moderna bags $1.5 billion 5-Yr loan to boost financial flexibility
By IPP Bureau - November 24, 2025
The non-dilutive financing includes three tranches
Bayer’s experimental stroke drug could reshape secondary stroke prevention
By IPP Bureau - November 24, 2025
Millions of stroke survivors across the world may soon have a new defense
Mesoblast teams with NIH to launch pivotal trial of life-saving cell therapy in adults with severe aGvHD
By IPP Bureau - November 24, 2025
The therapy -- Ryoncil (remestemcel-L-rknd) -- will be tested in adults with severe steroid-refractory acute graft-versus-host disease
Alvotech and Advanz Pharma secure European nod for Gobivaz, first biosimilar to Simponi
By IPP Bureau - November 24, 2025
Gobivaz is authorised for adults with rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (with or without methotrexate), axial spondyloarthritis, and ulcerative colitis
Texas hits Sanofi, Bristol-Myers Squibb with lawsuit over blood thinner drug efficacy
By IPP Bureau - November 24, 2025
Paxton alleges the companies marketed Plavix as a reliable defense against heart attacks, strokes, and blood clots while failing to disclose evidence that the drug could be ineffective or virtually useless for many people
GSK's TESARO sues AnaptysBio over alleged breach of cancer drug licence deal
By IPP Bureau - November 24, 2025
