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3155 News Found

Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules
Drug Approval | October 19, 2021

Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules

The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg


U.S. FDA authorises new saliva sample collection for Covid-19
Medical Device | October 19, 2021

U.S. FDA authorises new saliva sample collection for Covid-19

The Amplitude Solution gives laboratories the ability to scale Covid-19 PCR testing and process up to 8,000 samples a day


U.S. FDA approves Roche’s Tecentriq as adjuvant treatment for small cell lung cancer
Drug Approval | October 18, 2021

U.S. FDA approves Roche’s Tecentriq as adjuvant treatment for small cell lung cancer

Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting


Imfinzi plus tremelimumab significantly improved overall survival in liver cancer
Biotech | October 18, 2021

Imfinzi plus tremelimumab significantly improved overall survival in liver cancer

The trial met the primary endpoint of overall survival with a single priming dose of tremelimumab plus Imfinzi every four weeks vs. sorafenib


U.S. FDA advisory committee recommends J&J booster dose
Biotech | October 18, 2021

U.S. FDA advisory committee recommends J&J booster dose

U.S. FDA to decide whether to authorize a booster dose in the coming days


Granules gets ANDA approval for Dofetilide capsules
Drug Approval | October 18, 2021

Granules gets ANDA approval for Dofetilide capsules

The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm


Dr Reddy’s Lab launches carmustine in the US market
Drug Approval | October 16, 2021

Dr Reddy’s Lab launches carmustine in the US market

The BiCNU brand and generic market had U.S. sales of approximately US $ 19.4 million MAT for the most recent twelve months ending in August 2021, according to IQVIA Health


Exelixis in-licenses second anti-cancer compound from Aurigene
Biotech | October 15, 2021

Exelixis in-licenses second anti-cancer compound from Aurigene

U.S. FDA has accepted the investigational new drug application for phase 1 clinical trial in non-Hodgkin’s lymphoma


AUM Biosciences closes US $ 27 million `Series A’ funding round
Startup | October 15, 2021

AUM Biosciences closes US $ 27 million `Series A’ funding round

Everlife leads the series A round, and SPRIM Global Investments participates in the financing syndicate


IOL receives Korean FDA approval
Drug Approval | October 14, 2021

IOL receives Korean FDA approval

The company’s pharmaceutical API products Ibuprofen and fenofibrate got the go-ahead