You are here: Industry Insights > FDA

News List

Indian pharma: Driving excellence in quality and patient centricity expresspharma
December 04, 2020
The Indian pharma industry has recorded tremendous growth over the decades, more so during the pandemic. The Indian pharma sector has continued to be one of the key stakeholders in the pharma supply chain, providing access to affordable and quality ...
Roche's Xolair gets US nod for nasal polyps treatment pharmatimes
December 03, 2020
Roche’s asthma med Xolair has scored approval from the US Food and Drug Administration (FDA) for the treatment of nasal polyps in adults.
Catalyst Receives Fast Track Designation for Hemophilia Episodic Bleeding Treatment americanpharmaceuticalreview
December 03, 2020
Catalyst Biosciences announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Marzeptacog alfa (activated) – or MarzAA, the Company’s subcutaneously (SQ) administered next-generation engineered coagulation ...
FDA Lifts Hold on Multiple Myeloma Study americanpharmaceuticalreview
December 03, 2020
Cellectis announced the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 1 MELANI-01 trial evaluating the UCARTCS1 product candidate for the treatment of patients with relapsed or refractory multiple myeloma (MM).
Genentech gets US FDA nod for Gavreto to treat RET-mutant, RET fusion-positive thyroid cancers expresspharma
December 03, 2020
Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations.
Rhizen Pharma gets USFDA approval for Phase I trials of COVID-19 drug expresspharma
December 03, 2020
The initial study would evaluate single ascending doses of the RP7214 in healthy volunteers and that dosing is expected to commence in early December.
Alembic Pharma gets final nod form US FDA for Metolazone Tablets expresspharma
December 03, 2020
Metolazone Tablets are indicated for the treatment of salt and water retention and hypertension.
FDA grants COVID-19 treatment Fast Track designation europeanpharmaceuticalreview
December 02, 2020
The designation should expedite the development and review of AB201, a recombinant protein therapy being tested in hospitalised COVID-19 patients.
Glenmark gets tentative approval from US FDA for Axitinib Tablets, 1 mg and 5 mg expresspharma
December 02, 2020
Glenmark Pharmaceuticals has received tentative approval by the United States Food & Drug Administration (US FDA) for Axitinib Tablets, 1 mg and 5 mg, the generic version of Inlyta Tablets, 1 mg and 5 mg, of PF Prism C.V.
Lupin gets US FDA approval for Penicillamine Tablets expresspharma
December 02, 2020
They are indicated in the treatment of Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis.

Previous page 1 2 3 4 5 6 7 8 9 10 ... 367 368 Next page