Zydus Lifesciences bags USFDA nod for sleep disorder drug Triazolam Ruchika Sharma30 Dec 2022 5:16 PM ISTAhmedabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and...
Stelis Biopharma CDMO partner gets USFDA nod for key ANDA Ruchika Sharma28 Dec 2022 3:19 PM ISTBengaluru: Stelis Biopharma Limited, an emerging biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and the biologics arm of...
USFDA nod to Alembic Pharma breast cancer injection Fulvestrant Ruchika Sharma26 Dec 2022 1:15 PM ISTFulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of breast cancer.
Roche bags USFDA approval for Lunsumio to treat follicular lymphoma Ruchika Sharma24 Dec 2022 2:00 PM ISTFollicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.
Gilead Sciences bags USFDA nod for Sunlenca to treat HIV-1 infection Ruchika Sharma23 Dec 2022 4:09 PM ISTLenacapavir is a breakthrough innovation with the potential to be a preferred and versatile foundational long-acting agent due to its therapeutic...
Zydus Lifesciences subsidiary bags USFDA nod to market pulmonary arterial hypertension drug Selexipag Ruchika Sharma22 Dec 2022 4:35 PM ISTThe drug will be manufactured in the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
Alembic Pharma gets PAS approval from USFDA for Pregabalin Capsules Ruchika Sharma22 Dec 2022 3:32 PM ISTPregabalin Capsules are indicated for neuropathic pain, postherpetic neuralgia, and other indications.
Roche Actemra gets USFDA okay to treat COVID in hospitalised adults Ruchika Sharma22 Dec 2022 11:15 AM ISTBasel: Roche has announced that the U.S. Food and Drug Administration (FDA) has approved Actemra (tocilizumab) intravenous (IV) for the treatment of...
Lupin bags USFDA nod for generic equivalent of Briviact Tablets Ruchika Sharma21 Dec 2022 1:45 PM ISTThe product will be manufactured at Lupin's facility in Nagpur, India.
Abbott gets USFDA nod for smallest implantable spinal cord stimulation system for chronic pain Ruchika Sharma20 Dec 2022 4:04 PM ISTPaired with Abbott's new Xtend energy technology, Eterna optimizes the patient charging experience, requiring as few as five recharges per year under...
Glenmark Pharma bags USFDA nod for high BP drug Nicardipine Hydrochloride Ruchika Sharma20 Dec 2022 12:38 PM ISTMumbai: Drugmaker, Glenmark Pharmaceuticals Limited, has announced that the company has received final approval from the United States Food &...
USFDA inspection: Alembic Pharma gets Form 483 with 5 observations Ruchika Sharma19 Dec 2022 2:55 PM ISTVadodara: Drugmaker, Alembic Pharma, has recently announced that the company has received a Form 483 with 5 procedural observations from US Food...
