You are here: Industry Insights > USFDA

News List

USFDA concludes inspection of Unichem Lab’s Ghaziabad facility expressbpd
March 12, 2019
The inspection was successfully conducted from March 3-8, 2019, without any USFDA form 483 being issued
Strides Pharma Science arm gets USFDA nod for anti-epileptic drug expressbpd
February 21, 2019
The approved product is a generic version of Zarontin Capsules, 250 mg, of Pfizer
USFDA accepts Merck and Pfizer’s sBLA for Renal Cancer drug biospectrumasia
February 13, 2019
The clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs and more than 9,000 patients evaluated across more than 15 different tumor types.
I-Mab gets USFDA IND approval for its proprietary TJC4 biospectrumasia
January 30, 2019
I-Mab Biopharma (I-Mab) announced recently that its IND application for TJC4, has been approved by the US Food & Drug Administration (FDA).
Glenmark gets USFDA nod for generic Derma-Smoothe Topical Oil glenmark
October 31, 2018
Glenmark Pharmaceuticals received final approval from the US health regulator for generic version of Derma-Smoothe Topical Oil, used in the treatment of scalp psoriasis.
Zydus Cadila gets tentative nod from USFDA for diabetes drug financialexpress
September 12, 2018
The company has received tentative approval from the United States Food and Drug Administration (USFDA) for Sitagliptin tablets
Zydus Cadila gets USFDA nod for herpes viruses treatment drug financialexpress
September 06, 2018
Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Acyclovir Sodium Injection, 500 mg/10 mL and 1,000 mg/20mL single-dosevials, Cadila Healthcare said in a BSE filing.
Merck bags USFDA approval for 2 new HIV drugs biospectrumasia
September 05, 2018
Since the beginning of the epidemic, more than 70 million people have been infected with the HIV virus and about 35 million people have died of HIV
Zydus Cadila gets USFDA nod to market 2 products financialexpress
September 03, 2018
Gemfibrozil tablets are used together with diet to treat very high cholesterol and triglyceride levels in people with pancreatitis, Zydus Cadila said
Shire receives USFDA nod for TAKHZYRO biospectrumasia
August 28, 2018
TAKHZYRO is the only monoclonal antibody (mAb) that provides targeted inhibition of plasma kallikrein, an enzyme which is chronically uncontrolled in people with hereditary angioedema, to help prevent attacks

Previous page 1 2 3 4 5 Next page