Drug Approval | 01 March 2022
USFDA approves CITI Biopharma’s Vonjo
Vonjo is the first approved therapy to specifically address the needs of adult cytopenic myelofibrosis patients
Vonjo is the first approved therapy to specifically address the needs of adult cytopenic myelofibrosis patients
The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China
Divalproex Sodium Extended-Release tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches
In a European work-sharing procedure (WSP), Glucophage was approved as the first oral anti-diabetic medication to be used safely from conception to birth
Keytruda plus Lenvima is also approved in the U.S. and Europe for the first-line treatment of adult patients with advanced RCC.
Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad
Therapeutic use of the product is for short term symptomatic relief of colds, chills and influenza including chesty coughs
To be marketed by Strides Pharma Inc. in the US market
Since the beginning of the pandemic, more than one million patients with severe COVID-19 have been treated with Actemra/RoActemra
Phase 2a clinical proof-of-concept biomarker study for PXL065 in ALD now anticipated to start midyear
Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market
Tepmetko is the first and only oral MET inhibitor to be approved in the European Economic Area for treating adult patients with advanced NSCLC harboring alterations leading to METex14 skipping, who require systemic therapy following prior treatment
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
With this approval, Brukinsa is now approved in 44 markets as BeiGene continues to advance its global registration, including the EU, US, and Great Britain
The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV
Parkinson's disease treatment is the first and only carbidopa/levodopa (CD/LD) tablet designed to be divided for precise dosing
Bebtelovimab neutralizes Omicron as demonstrated by pseudo virus and authentic virus data
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