The approval is based on results from the pivotal Phase 3 SOLARIS trial, which demonstrated overall symptom improvement
The supplemental New Drug Application (sNDA) was based on the positive Phase III FIND-CKD study results
Granules India believes it may qualify for first-to-file status for Ruxolitinib Extended-Release Tablets, subject to FDA review and determination
The FDA granted one designation for Temab-A in combination with bevacizumab for adults with refractory, metastatic colorectal cancer
The filing is backed by results from the global Phase III SAFFRON trial
The new patent is distinct from and additive to Chinese Patent No. ZL202511246578.X, which covers methods for synthesizing capped RNA molecules
The product will be manufactured at Unit-IV of APL Healthcare
The approval is based on results from the Phase 3 SCOUT-HCM trial, which enrolled 44 adolescents aged 12 to under 18 with symptomatic oHCM
The filing seeks approval of fenebrutinib for adults with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS)
There were no data integrity related observations
The Patent covers V-ATPase-inhibiting compounds and their use in treating viral infections
AbbVie said that JUVMO is the first and only selective D1/D5 receptor agonist approved for adults with Parkinson’s disease
First-time-in-India approval strengthens Akums’ presence in the growing cardiovascular therapeutics segment
The filing marks a major regulatory step for Gossamer as it seeks to bring seralutinib to patients with pulmonary arterial hypertension
The FDA approval of Lyrfigtu introduces a vital second-line treatment option for patients living with CCA and their families
Amneal said the product will launch immediately, adding another complex injectable to its growing Affordable Medicines portfolio
First U.S. ANDA submitted for Sitagliptin Tablets USP in three strengths
Lupin's Apixaban Oral Suspension 1.25 mg/mL is a liquid version of the blood-thinner apixaban
The approval marks a new treatment option for patients with advanced kidney cancer following immunotherapy
The decision follows discussions with the U.S. Food and Drug Administration (FDA) which indicated that the data submitted in support of the application do not meet the requirements for accelerated approval
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