The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules of Boehringer lngelheim
Merzee is a generic equivalent of Taytulla of Allergan Pharmaceuticals International
Immunocin, an Immuno-modulator drug, significantly reduced the risk of death in the Phase 3 clinical trial in adult patients with moderate-to-severe Covid-19
Aveir VR is specifically designed to be retrieved when therapy needs to evolve or the device needs to be replaced
Ondexxya is the first approved reversal agent specifically for Factor Xa inhibitors, providing a major advance in the treatment of patients hospitalised with life-threatening bleeding
Approval is based on results of a multicenter, randomized, open-labeled and controlled IDE clinical study that demonstrated the superiority of Agili-C™ implant to the current surgical standard of care, debridement and microfracture in the knee joint
Ozempic is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults
Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients
In May 2021, Daiichi Sankyo had submitted a supplemental new drug application (sNDA) for Tarlige tablets based on results from a phase 3 trial in patients with CNP
Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months
It also empowers domestic precision immunotherapy for tumours and promotes the high-quality development of China's biopharmaceutical industry
Aquavit will officially unveil the Dermatox and Microtox programs at the Annual American Academy of Dermatology, the world's largest dermatology conference scheduled from March 25-29, 2022, in Boston, MA
Cabenuva was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen's decades-long commitment to combatting HIV
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
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