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
The filing is based on results from the Phase III VOLGA trial
Lilly said Onswik is intended for use alongside diet and exercise to control high blood sugar
The FDA is not bound by the panel’s recommendations and will make the final regulatory decision
RINVOQ's new indication continues to build on our differentiated immunology portfolio with breadth and depth across therapeutic areas and patient populations
Glenmark Pharma clears USFDA audit for Goa plant with VAI status
The approval gives patients in Europe an alternative to frequent intravitreal eye injections
The European Commission approval follows the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use
Dr. Rajeev Singh Raghuvanshi outlined next phase of India’s drug regulatory reforms and also revealed plans to create 1,500 new positions to strengthen CDSCO's internal scientific capabilities
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