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Results For "approvaL"

2469 News Found

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Biotech | December 21, 2021

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA

Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers


Novartis collaborates with BeiGene to strengthen immunotherapy pipeline
Biotech | December 21, 2021

Novartis collaborates with BeiGene to strengthen immunotherapy pipeline

Innovative market development collaboration also signed, expanding the availability of select Novartis oncology products in regions across China currently not covered by Novartis


U.S. FDA approves first and only injectable option for HIV prevention
Drug Approval | December 21, 2021

U.S. FDA approves first and only injectable option for HIV prevention

Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition


Shilpa Medicare launch Prucalshil for treatment of constipation
Drug Approval | December 21, 2021

Shilpa Medicare launch Prucalshil for treatment of constipation

Prucalopride medicine in the form of Orally Disintegrating Strips are most convenient dosage form for geriatric patients


U.S. FDA approves ANI’s rifabutin capsules, launch soon
Drug Approval | December 21, 2021

U.S. FDA approves ANI’s rifabutin capsules, launch soon

The capsules are the generic version of the reference listed drug Mycobutin


Merck’s tepmetko receives positive CHMP opinion in Europe
Biotech | December 20, 2021

Merck’s tepmetko receives positive CHMP opinion in Europe

The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping


USFDA grants Orphan Drug Designation to Zydus’ novel compound to treat malaria
Biotech | December 16, 2021

USFDA grants Orphan Drug Designation to Zydus’ novel compound to treat malaria

ZY19489 is a novel anti-malarial compound active against all current clinical strains of P. falciparum and P. vivax, including drug resistant strains


Aragen Life Sciences acquires Intox
Biotech | December 15, 2021

Aragen Life Sciences acquires Intox

Intox is a GLP certified pre-clinical contract research organization with its test facilities in Pune


Govt includes seven more companies under PLI scheme
News | December 10, 2021

Govt includes seven more companies under PLI scheme

Approvals accorded under Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical Key Starting Materials (KSMs)/ drug intermediates and Active Pharmaceutical Ingredients (APIs


China approves Brii Bio’s antibody combination to neutralise Covid-19
Drug Approval | December 10, 2021

China approves Brii Bio’s antibody combination to neutralise Covid-19

Brii Bio announces amubarvimab/romlusevimab combination received approval from NMPA