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Zydus receives final approval from the USFDA for Sildenafil for Oral Suspension
Drug Approval | October 01, 2022

Zydus receives final approval from the USFDA for Sildenafil for Oral Suspension

Sildenafil for Oral Suspension had annual sales of USD 65 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).


Lupin receives US FDA approval for Mirabegron Extended-Release tablets
Drug Approval | September 30, 2022

Lupin receives US FDA approval for Mirabegron Extended-Release tablets

Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US


Lupin receives warning letter from US FDA
Drug Approval | September 30, 2022

Lupin receives warning letter from US FDA

The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility


Lupin launches Sildenafil for Oral Suspension in US
Drug Approval | September 30, 2022

Lupin launches Sildenafil for Oral Suspension in US

Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US


Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age
Drug Approval | September 27, 2022

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age

The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses


Lynparza approved in China as first-line maintenance treatment with Bevacizumab for HRD- positive advanced ovarian cancer
Drug Approval | September 23, 2022

Lynparza approved in China as first-line maintenance treatment with Bevacizumab for HRD- positive advanced ovarian cancer

One in two women with advanced ovarian cancer has an HRD-positive tumor


Cipla receives EIR for Indore plant, Aurbindo for Raleigh
News | September 23, 2022

Cipla receives EIR for Indore plant, Aurbindo for Raleigh

The plant at Raleigh, North Carolina, USA owned by Aurolife Pharma has received an establishment inspection report (EIR)


BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin
Drug Approval | September 22, 2022

BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin

NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.


Zydus launches Lenalidomide Capsules
News | September 22, 2022

Zydus launches Lenalidomide Capsules

Lenalidomide is used to treat various types of cancers.


Merck to initiate new Phase 3 clinical program for treatment of HIV-1 Infection
Diagnostic Center | September 21, 2022

Merck to initiate new Phase 3 clinical program for treatment of HIV-1 Infection

Phase 2 study evaluating an investigational weekly oral combination treatment regimen of islatravir and Gilead Sciences’ lenacapavir to resume with lower dose of islatravir