You are here: Industry Insights > FDA

News List

Syapse, FDA Announce RCA Using Real-World Evidence contractpharma
August 16, 2019
Focus on advancing real-world oncology endpoints and providing insight into evidence-based clinical decision-making.
FDA Approves New Treatment for Drug-Resistant TB contractpharma
August 16, 2019
Pretomanid is only the third new anti-TB drug approved by FDA in more than 40 years.
FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs worldpharmanews
August 16, 2019
The U.S. Food and Drug Administration today approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs.
Dr. Reddy's Copaxone, NuvaRing generics derailed by FDA fiercepharma
August 15, 2019
Dr. Reddy’s, which has been dealing with repeated manufacturing setbacks from the FDA, is now facing a new regulatory challenge.
DynoSense gets FDA approval for unique cloud based system biospectrumasia
August 15, 2019
The world's first most integrated and cloud-based vital signs measuring and recording platform
FDA to deactivate out-of-date drug listings in its database europeanpharmaceuticalreview
August 15, 2019
In order keep up-to-date records and protect public health the FDA has announced it intends to deactivate out-of-date drug listings.
Strides completes US FDA inspection at its Alathur facility expresspharma
August 15, 2019
Strides Pharma Science recently announced that its formulation facility at Alathur, Chennai, India underwent a US FDA inspection starting August 05, 2019 and the inspection concluded with “Zero 483 observations”.
Indoco’s CRO – AnaCipher clears US FDA inspection with ZERO 483 expresspharma
August 15, 2019
Indoco Remedies announced that its Clinical Research Organisation, AnaCipher , located at Hyderabad had undergone a walk-in surveillance inspection by the United States Food and Drug Administration (division of New Drug Bioequivalence Evaluation) from 5th
FDA Approves Drug for Treatment-Resistant forms of TB americanpharmaceuticalreview
August 15, 2019
The U.S. Food and Drug Administration (FDA) approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs.
FDA Approves Pretomanid for Highly Drug-Resistant Forms of Tuberculosis drugs
August 15, 2019
Pretomanid, a novel compound developed by the non-profit organization TB Alliance, was approved by the U.S. Food & Drug Administration (FDA) for treating some of the most drug-resistant forms of tuberculosis (TB).

Previous page 1 2 3 4 5 6 7 8 9 10 ... 366 367 Next page