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1474 News Found

U.S. FDA approves Novartis Leqvio to lower cholestrol
Drug Approval | December 23, 2021

U.S. FDA approves Novartis Leqvio to lower cholestrol

With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction1


Novartis to acquire Gyroscope Therapeutics for up to US $ 1.5 bn
Biotech | December 22, 2021

Novartis to acquire Gyroscope Therapeutics for up to US $ 1.5 bn

Acquisition will add GT005 to the Novartis portfolio, an investigational, one-time gene therapy currently in Phase 2 for the treatment of people living with Geographic atrophy


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


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


NMPA approves CStone's NDA for Cejemly
Drug Approval | December 21, 2021

NMPA approves CStone's NDA for Cejemly

The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC 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


Cipla receives final approval for Lanreotide injection
Drug Approval | December 20, 2021

Cipla receives final approval for Lanreotide injection

It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours


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


Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant
News | December 17, 2021

Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant

The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research


U.S. FDA approves Bristol Myers Squibb’s Orencia
Drug Approval | December 16, 2021

U.S. FDA approves Bristol Myers Squibb’s Orencia

Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant