USFDA

18 April 2025

Lupin Receives EIR from US FDA for its Injectable Facility in Nagpur

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

27 March 2025

Aspen Biopharma Labs gets warning letter from USFDA

The U.S. Food and Drug Administration inspected Aspen Biopharma Labs Private Limited, drug facility; at Rangareddy region from September 16 to September 21, 2024. And they get a warning letter which summarizes significant deviations from Current Good Manufacturing Practice CGMP for active pharmaceutical ingredients.

26 March 2025

Blujepa (gepotidacin) approved by USFDA for treatment of uncomplicated urinary tract infections

Discovered by GSK scientists, Blujepa is a first-in-class oral antibiotic with a novel mechanism of action that is part of GSK’s infectious diseases portfolio.

21 March 2025

Novartis receives third FDA approval for oral Fabhalta® (iptacopan)

Novartis announced that oral Fabhalta iptacopan has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for this condition.

19 March 2025

Zydus receives final approval from USFDA for Apalutamide Tablets, 60 mg

Zydus Life sciences Limited has received final approval from the United States Food and Drug Administration USFDA to manufacture Apalutamide Tablets, 60 mg.

26 February 2025

USFDA accepts Bristol Myers Squibb’s Supplemental Biologics License Application for Opdivo® Plus Yervoy®

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application for Opdivo nivolumab plus Yervoy ipilimumab as a potential first-line treatment option for adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high MSI-H or mismatch repair deficient dMMR colorectal cancer

24 February 2025

FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease

the U.S. Food and Drug Administration approved Ctexli for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, a very rare lipid storage disease.

18 February 2025

MED-EL USA gets FDA approval for cochlear implant

MED-EL USA announced that the U.S. Food and Drug Administration approved the new SONNET 3 audio processor for MED-EL cochlear implants. SONNET 3 is the companys lightest and smallest behind-the-ear audio processor and features integrated wireless direct streaming capabilities.

30 December 2024

Halozyme Announces FDA approval of Bristol Myers Squibb's Opdivo Qvantig™ with ENHANZE

Halozyme Therapeutics, Inc announced that Bristol Myers Squibb received U.S. Food and Drug Administration (FDA) approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) co-formulated with Halozyme's ENHANZE® drug delivery technology for subcutaneous use in most previously approved adult, solid tumor intravenous (IV) Opdivo® indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

25 December 2024

FDA approves Zepbound as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity

Eli Lilly and Company announced the U.S. Food and Drug Administration approved Zepbound tirzepatide as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea OSA and obesity.

Search

Lupin Receives EIR from US FDA for its Injectable Facility in Nagpur

RECOMMENDED POSTS

Subscribe with us

Jobs by Category