Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 22

Results For "FDA-approval"

460 News Found

Aadi Bioscience secures U.S FDA approval of its first product Fyarro
Drug Approval | November 26, 2021

Aadi Bioscience secures U.S FDA approval of its first product Fyarro

Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa in adults


Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules
Drug Approval | November 23, 2021

Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules

Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)


Zydus Cadila receives U.S.FDA approval for leukaemia injection
Drug Approval | November 18, 2021

Zydus Cadila receives U.S.FDA approval for leukaemia injection

Nelarabine is in a class of medications called antimetabolites


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


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


Zydus Cadila gets US FDA approval for antidepressant tablets
Drug Approval | September 09, 2021

Zydus Cadila gets US FDA approval for antidepressant tablets

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


Caplin Steriles gets US FDA approval for blood pressure injection
News | September 08, 2021

Caplin Steriles gets US FDA approval for blood pressure injection

Labetalol hydrochloride injection USP is indicated for the control of blood pressure in severe hypertension.


Omeza Collegen Matrix gets U.S. FDA approval
Biotech | September 03, 2021

Omeza Collegen Matrix gets U.S. FDA approval

This is Omeza’s first Rx product and the first drug/device combination matrix of its kind for chronic wound care


Janssen announces U.S. FDA approval of Invega Hafyera
Drug Approval | September 02, 2021

Janssen announces U.S. FDA approval of Invega Hafyera

Invega Hafyera offers patients the fewest doses per year. Phase 3 non-inferiority study results showed over 92% of participants were relapse-free at 12 months


Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test
Drug Approval | August 30, 2021

Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test

The Visby Medical sexual health click test is the first instrument-free PCR test for the detection of chlamydia, gonorrhoea and trichomonas, with results available within 30 minutes, during the patient visit