Biotech | August 11, 2021
Penpulimab Monoclonal Antibody (PD-1) Obtains Marketing Approval in China
The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial
The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial
TSC causes epilepsy in up to 85 % of patients, and up to 60 % of those patients do not respond to standard anti-seizure medicines
The product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients
The group now has 320 approvals and has so far filed over 400 ANDAs
Sumatriptan Injection USP is indicated in adults for acute treatment of migraine with or without aura, and acute treatment of cluster headache
The company has already embarked upon significant expansion in Turkey
In the interim, the statutory approvals obtained by the company under SEBI ICDR have lapsed in accordance with applicable law and are required to be re-obtained
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
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