Drug Approval | 08 June 2023
European Commission authorises GSK’s Arexvy for older adults
Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time
Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time
Injectafer is now the first and only intravenous (IV) iron replacement therapy indicated for adult patients with heart failure who have iron deficiency
European approval is based on robust Phase III data showing Cosentyx provided rapid symptom relief from as early as Week 4, with response rates continuing to improve up to 1 year1,3-5
Tremelimumab in combination with Durvalumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC)
The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 2023).
For the treatment of Superficial Femoral Artery
The product is expected to be launched in June 2023
The approval paves the way for consolidating the company’s position in Kenya and other African markets as part of its global expansion plans
This is the second US FDA GMP inspection of this facility within one year
Ephedrine Sulfate Injection USP, 50 mg/mL had annual sales of USD 52 mn in the United States
The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.
Venlafaxine HCl extended-release capsules are indicated for the treatment of: Major Depressive Disorder
This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites
VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
The company moves a step closer towards achieving its goal of emerging as the top oncology medicine supplier from India in the ASEAN region
The certification issued by the EDQM verifies the compliance of pharmaceutical substances
APP13007 is a novel aqueous nanosuspension formulation for the treatment of inflammation and pain following ocular surgery
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