Drug Approval | 25 March 2022
Japan approves BMS’ Breyanzi application for relapsed large B-cell lymphoma
This is the first CAR T cell therapy application filed for the second-line treatment of R/R LBCL in Japan
This is the first CAR T cell therapy application filed for the second-line treatment of R/R LBCL in Japan
The product will be manufactured at Lupin’s facility in Goa, India
USFDA also approved complementary diagnostic imaging agent, Locametz, after radiolabeling with gallium-68 for the identification of PSMA-positive lesions
The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age
It is the fourth vaccine to get the nod for 12 years and older after Biological E’s Corbevax, Bharat Biotech’s Covaxin and Zydus Lifesciences Zy-CoV-D
The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial
According to IQVIA sales data for the period ending January 2022, Vimpat tablets market achieved annual sales of approx. US $ 1.7 billion
The company plans to launch the product immediately
Nasonex is a registered trademark of Organon and is used by Perrigo and its affiliates under license
The drug is indicated for use in combination with other drugs
The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older
The generic version of Sinequan, which is used for the treatment of anxiety, depression, and other target symptoms of psychoneurosis
Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab
First and only FDA-approved treatment for seizures associated with CDKL5 deficiency disorder (CDD) in patients two years of age and older
First approved in 2019, Rinvoq is a JAK inhibitor approved for four indications across gastroenterology, dermatology and rheumatology
First PARP inhibitor to demonstrate overall survival benefit in early breast cancer
Nebivolol is used alone or together with other medicines to treat high blood pressure
This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing)
It is only the second generic application approved by the USFDA
Macitentan tablets, 10 mg have an estimated market size of US $ 797 million for twelve months ending Dec 2021 according to IQVIA
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