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Results For "approvaL"

2684 News Found

WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site
Biotech | March 04, 2022

WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site

WuXi STA’s drug product site in Wuxi City offers a full range of services including formulation development and manufacturing for a broad range of oral and injectable dosage forms


Cipla gets approval from SEC to conduct Paxlovid trials
News | March 03, 2022

Cipla gets approval from SEC to conduct Paxlovid trials

Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations


Lupin receives USFDA approval for topical solution
Drug Approval | March 03, 2022

Lupin receives USFDA approval for topical solution

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


Amneal enters U.S. biosimilars market with approval of Releukotm
Drug Approval | March 02, 2022

Amneal enters U.S. biosimilars market with approval of Releukotm

First of three Amneal biosimilars expected for U.S. approval and launch in 2022


Unichem receives ANDA approval for bipolar disorder drug
Drug Approval | February 28, 2022

Unichem receives ANDA approval for bipolar disorder drug

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


Medtronic receives USFDA approval for InterStim X system to manage bladder and bowel control
Medical Device | February 23, 2022

Medtronic receives USFDA approval for InterStim X system to manage bladder and bowel control

New InterStim X system provides 10 to 15 years of battery life without the need to recharge


Zydus receives USFDA approval for Dapagliflozin tablets
Drug Approval | February 23, 2022

Zydus receives USFDA approval for Dapagliflozin tablets

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad


Abbott's CardioMEMS HF System receives USFDA approval
Medical Device | February 22, 2022

Abbott's CardioMEMS HF System receives USFDA approval

New expanded indication provides patients suffering from earlier stages of heart failure access to the CardioMEMS HF System, a small implantable sensor that can flag early warning signs of worsening heart failure


Strides receives USFDA approval for Amantadine Hydrochloride capsules
Drug Approval | February 21, 2022

Strides receives USFDA approval for Amantadine Hydrochloride capsules

To be marketed by Strides Pharma Inc. in the US market


Kato wins USFDA approval for studies in retinal disorder
Biotech | February 17, 2022

Kato wins USFDA approval for studies in retinal disorder

Resolv ER may remedy leading causes of blindness in adults