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Results For "FDA"

2071 News Found

Piramal Pharma Solutions new API plant in Canada goes online
Biotech | May 19, 2022

Piramal Pharma Solutions new API plant in Canada goes online

It is part of the company's CAD $30 million capital investment in the Aurora, Canada site


Sun Pharma to launch Brillo, a first-in-class oral lipid-lowering drug in India
Drug Approval | May 18, 2022

Sun Pharma to launch Brillo, a first-in-class oral lipid-lowering drug in India

Bempedoic Acid administered as a 180-mg dose, is approved by the USFDA and European Union for the treatment of hypercholesterolemia


Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years
Drug Approval | May 18, 2022

Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years

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


Antengene announces commercial availability of Xpovio in China
Biotech | May 16, 2022

Antengene announces commercial availability of Xpovio in China

The drug will be available in 600 hospitals and 105 DTPs


Takeda launches Adynovate for Hemophilia patients in India
News | May 16, 2022

Takeda launches Adynovate for Hemophilia patients in India

Adynovate in combination with Mypkfit offers personalized treatment and enables HCPs and patients to monitor factor levels from home and help achieve optimum QOL outcomes


Tirzepatide has potential to drive weight loss market dramatically, observes GlobalData
Biotech | May 15, 2022

Tirzepatide has potential to drive weight loss market dramatically, observes GlobalData

Tirzepatide is primarily indicated for the treatment of T2D and is expected to receive its decision from the FDA in Q2 2022


Neurocrine Biosciences receives Orphan Drug Designation for Valbenazine
Biotech | May 13, 2022

Neurocrine Biosciences receives Orphan Drug Designation for Valbenazine

The treatment of chorea associated with HD is within the scope of this Orphan Drug Designation


First patient dosed with antiepileptic drug candidate CB03 in a first-in-human Phase I trial
Biotech | May 12, 2022

First patient dosed with antiepileptic drug candidate CB03 in a first-in-human Phase I trial

CB03 is a candidate drug for the treatment of refractory epilepsy, independently developed by Zhimeng


Suven Pharmaceuticals - CDMO core growth intact; formulations to pick up
News | May 12, 2022

Suven Pharmaceuticals - CDMO core growth intact; formulations to pick up

Anand Rathi maintains long-term guidance of 10-15% revenue growth and 40% EBITDA margins


Ascletis announces U.S. IND approval of ASC22 for HIV patients
Biotech | May 11, 2022

Ascletis announces U.S. IND approval of ASC22 for HIV patients

ASC22 (Envafolimab) is a subcutaneously administered single-domain antibody against PD-L1 and has the potential to restore virus-specific immune responses in patients with chronic viral infection