Drug Approval | 01 June 2022
FDA approves Roche’s Evrysdi for use in babies under two months with SMA
Evrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to date
Evrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to date
Avillion announces expansion of partnership with AstraZeneca on PT027 and will fund and execute a new Phase 3b study
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil)
Perrigo expects to launch Omeprazole Minis later this year
Pemetrexed for injection is indicated for the treatment of Antineoplastics (medications used to treat cancer)
Pemetrexed for Injection has a market size of USD 1,236 mn (as per IQVIA MAT March’22)
This Keytruda combination is the first immunotherapy option approved in the EU for high-risk early-stage TNBC
Belmore, the brand name of Bempedoic acid, is a novel drug for the treatment of high LDL-cholesterol.
The tablets have an estimated market size of US $ 548 million for twelve months ending December 2021 according to IQVIA
Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU-approved mRNA Covid-19 vaccine
Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease that can lead to substantial burden and often disability among patients
Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of USFDA’s Priority Review action date
According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million
Abevmy follows the launch of the company’s two oncology biosimilars in Canada, Ogivri (bTrastuzumab) in 2019 – the first Trastuzumab approved in the country – and Fulphila (bPegfilgrastim), which was launched in 2020
With the approval from the Central Drugs Standard Control Organisation (CDSCO), Jardiance is now the first approved therapy to improve outcomes for the full spectrum of heart failure regardless of ejection fraction
Children 5 through 11 years of age are now authorized to receive a booster dose at least five months after the second dose of the two-dose primary series
Bempedoic Acid administered as a 180-mg dose, is approved by the USFDA and European Union for the treatment of hypercholesterolemia
Viralex (Inosine Pranobex) is an immunomodulatory agent with broad-spectrum antiviral properties
Quantib Prostate is an AI-based software solution that advances the MRI prostate reporting workflow and is accessible directly from the radiologist's reading station
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