Drug Approval | July 24, 2023
Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets
This product would be manufactured at Lupin's Nagpur facility in India
This product would be manufactured at Lupin's Nagpur facility in India
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union
If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU
The maker of ivermectin/pyrantel, the #1 vet-recommended and #1 dog-preferred real beef chew introduces the latest innovation in its portfolio
KEYTRUDA plus concurrent chemoradiotherapy demonstrated statistically significant and clinically meaningful improvement in PFS versus concurrent chemoradiotherapy alone in these patients
Deal includes DTx-1252, a potential therapy for the neuromuscular disorder Charcot-Marie-Tooth disease type 1A (CMT1A), and two additional preclinical programs for other neuroscience indications
Evonik specializes in mid- to large-scale, later clinical phase HPAPIs
The strategic acquisition demonstrates the company’s commitment to increasing OTC consumer convenience in eye care
SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets
Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU
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