FDA grants full approval for TIVDAK to treat cervical cancer

TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer

Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal

The USFDA has issued 5 observations pursuant to the completion of audit

Zydus receives final approval from USFDA for Tretinoin Cream

The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)

FDA approves Biktarvy label update with data for pregnant adults with HIV

Additional data in pregnant adults who are Virologically suppressed reinforce safety and tolerability profile of Biktarvy in broad range of people with HIV

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