You are here: Industry Insights > FDA

News List

FDA Approves Nivolumab Plus Cabozantinib for Advanced Renal Cell Carcinoma americanpharmaceuticalreview
January 28, 2021
The U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb) and cabozantinib (Cabometyx, Exelixis) as first-line treatment for patients with advanced renal cell carcinoma (RCC).
Unichem gets USFDA approval for Zonisamide Capsules expresspharma
January 28, 2021
They are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
Glenmark Pharma gets USFDA approval for Amphetamine Sulfate Tablets expresspharma
January 28, 2021
The tablets are used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy, a sleeping disorder.
Samsung Biologics, National OncoVenture, and Eutilex Obtain IND Approval from FDA prnasia
January 27, 2021
Samsung Biologics announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company's track record as a premiere CDO service provider in the ...
Oramed Doses Patients Across Multiple Sites in Phase 3 Oral Insulin Study americanpharmaceuticalreview
January 27, 2021
Oramed Pharmaceuticals announced randomization of patients in its first Phase 3 study of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes (T2D) is under way.
FDA Grants Accelerated Approval to Darzalex Faspro for Newly Diagnosed Light Chain Amyloidosis americanpharmaceuticalreview
January 27, 2021
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech) in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain (AL) ...
Voclosporin approved by FDA to treat lupus nephritis europeanpharmaceuticalreview
January 26, 2021
The FDA has approved Aurinia Pharmaceuticals’ LupkynisTM(voclosporin) for the treatment of lupus nephritis, alongside standard-of-care.
FDA Approves Nerivio for Acute Treatment of Migraine in Adolescents americanpharmaceuticalreview
January 26, 2021
Theranica announced its Nerivio® therapeutic device has received the U.S. Food and Drug Administration (FDA) clearance to market for an expanded indication for acute treatment of episodic or chronic migraine in people 12 years and older.
Lupin gets USFDA approval for Sevelamer Carbonate Tablets expresspharma
January 26, 2021
They are indicated for the control of serum phosphorus in adults and children six years of age and older with chronic kidney disease on dialysis.
Strides get USFDA nod for Ursodiol capsules expresspharma
January 26, 2021
Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte, Singapore, has received approval for Ursodiol Capsules USP, 300 mg from the United States Food & Drug Administration (USFDA).

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