Zydus Lifesciences gets 10 observations from USFDA for Jarod injectable facility

The company will closely work with the USFDA to address and respond to the observations in an expeditious manner

Marksans Pharma updates on USFDA inspection at Verna, Goa manufacturing facility

Roche gets FDA approval for Alecensa in early lung cancer

This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy

GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA

Submission based on results from pivotal phase III trial showing all primary endpoints met

Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers

USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria

NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections

Alvotech and Teva get US FDA approval of Selarsdi

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva

Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations

This facility manufactures APIs & formulations of oncology and non-oncology products.

USFDA completes inspection of Lupin's Dabhasa facility with no observations

The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations

Strides receives USFDA approval for Fluoxetine Tabs 10 mg and 20 mg

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly