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Results For "approval"

2474 News Found

UFDA approves first generic of Symbicort to treat asthma and COPD
Drug Approval | March 16, 2022

UFDA approves first generic of Symbicort to treat asthma and COPD

This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing)


I Peace triples GMP cell manufacturing by expanding CDMO facility
Biotech | March 15, 2022

I Peace triples GMP cell manufacturing by expanding CDMO facility

The facility registration, along with DMF registration and GMP certification provides peace of mind to clients looking to use our iPSCs for clinical and commercial use in the United States, Japan, and other global markets


USFDA grants Orphan Drug Designation for Akantior
Biotech | March 15, 2022

USFDA grants Orphan Drug Designation for Akantior

SIFI is currently evaluating various options for the commercialization of Akantior (polihexanide) globally, including potential out-license agreements outside its core markets


Biogen and Eisai amend collaboration agreements on Alzheimer’s disease treatments
News | March 15, 2022

Biogen and Eisai amend collaboration agreements on Alzheimer’s disease treatments

Aducanumab collaboration to convert from Eisai sharing of global profits and losses to a global royalty arrangement, effective January 1, 2023


AbbVie and Scripps Research plan to develop anti-viral for Covid-19
News | March 15, 2022

AbbVie and Scripps Research plan to develop anti-viral for Covid-19

The initial SARS-CoV-2 research program at Calibr, the drug discovery and development division of Scripps Research, was supported by funding from the Bill & Melinda Gates Foundation


USFDA approves Zydus’ Colestipol Hydrochloride tablets
Drug Approval | March 14, 2022

USFDA approves Zydus’ Colestipol Hydrochloride tablets

It is only the second generic application approved by the USFDA


USFDA clears Niramai's breast thermography device
News | March 14, 2022

USFDA clears Niramai's breast thermography device

The SMILE-100 System is a breast thermography device that helps healthcare personnel review, measure and analyze thermally significant indications in the breast region


New data show Lynparza demonstrated overall survival benefit in early breast cancer
Biotech | March 12, 2022

New data show Lynparza demonstrated overall survival benefit in early breast cancer

Lynparza is approved in the US, EU, Japan and several other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial


China approves BeiGene’s tislelizumab
Drug Approval | March 12, 2022

China approves BeiGene’s tislelizumab

Tislelizumab is now approved for seven indications in China


USFDA approves Lupin’s Vigabatrin oral solution
Drug Approval | March 11, 2022

USFDA approves Lupin’s Vigabatrin oral solution

The product will be manufactured at Lupin’s facility in Goa, India