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1151 News Found

Sanofi’s Dupixent pivotal trial meets all primary and secondary endpoints for treatment of atopic dermatitis
Biotech | August 31, 2021

Sanofi’s Dupixent pivotal trial meets all primary and secondary endpoints for treatment of atopic dermatitis

Results reinforce the well-established safety profile of Dupixent - the first-ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old


Granules India receives approval from Health Canada for arthritis drug
News | August 30, 2021

Granules India receives approval from Health Canada for arthritis drug

Acetaminophen extended-release tablets 650 mg is bioequivalent of the reference listed drug Tylenol


Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection
Drug Approval | August 27, 2021

Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection

The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials


Marksans announces US FDA approval for Acetaminophen Extended- Release tablets
News | August 27, 2021

Marksans announces US FDA approval for Acetaminophen Extended- Release tablets

The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India


Zydus gets USFDA approval for arthritis drug
News | August 23, 2021

Zydus gets USFDA approval for arthritis drug

Zydus was the first to file an ANDA for Tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength


Pfizer receives EC approval for XEIJANZ
Biotech | August 23, 2021

Pfizer receives EC approval for XEIJANZ

XELJANZ is the first and only Janus kinase (JAK) inhibitor approved in Europe for the treatment of polyarticular JIA and juvenile PsA and has received regulatory approval in four indications in the European Union, the most of any JAK inhibitor


US FDA approves Jardiance to treat adults living with heart failure with a reduced ejection fraction
Drug Approval | August 20, 2021

US FDA approves Jardiance to treat adults living with heart failure with a reduced ejection fraction

New treatment options are critical, as approximately half of all people with heart failure die within five years of diagnosis. Heart failure accounts for more than one million hospitalisations a year in the US


Novartis announces positive results from Phase 3 trials of Beovu for diabetes
Drug Approval | August 18, 2021

Novartis announces positive results from Phase 3 trials of Beovu for diabetes

Results from year two of the pivotal Phase 3 KITE clinical trial reaffirmed visual acuity gains and fluid reduction findings as well as safety profile from year one


Lupin receives tentative U.S. FDA approval for Brivaracetam tablets
Drug Approval | August 17, 2021

Lupin receives tentative U.S. FDA approval for Brivaracetam tablets

Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older


Zydus Cadila receives tentative approval for cancer drug
News | August 17, 2021

Zydus Cadila receives tentative approval for cancer drug

Lenalidomide is used to treat cancer and also some anaemia disorders