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

Positive data for Roche multiple sclerosis injection

US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024

Briefs: Sun Pharma and Kimia Biosciences

Sun Pharma's Dadra facility receives OAI status from US FDA

Dr. Reddy's launches drug-free migraine management device Nerivio in Europe

UroGen Pharma files patent infringement action against Teva Pharmaceuticals

Zydus receives approval for the name 'Usnoflast' as recommended name for ZYIL1 from WHO International Non-proprietary Names

Usnoflast (ZYIL1) is a novel oral small molecule NLRP3 inhibitor discovered at Zydus

Viatris launches RYZUMVl 0.75% in US

The average time of dilation lasts three to eight hours

AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer

Application based on results from the TROPION-Breast01 Phase III trial

FDA Granted ODD to Utidelone Injectable from Biostar Pharma for treatment of breast cancer brain metastasis

Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux

Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024