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Results For "FDA-approval"

438 News Found

Camzyos is the first and only USFDA-approved cardiac myosin inhibitor
Biotech | April 29, 2022

Camzyos is the first and only USFDA-approved cardiac myosin inhibitor

Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo


Malaysia awards three-year contract for Biocon Biologics’ Insugen
Biotech | April 26, 2022

Malaysia awards three-year contract for Biocon Biologics’ Insugen

Biocon Biologics’ Insugen formulations will be available to patients at all Ministry of Health hospitals, district health offices and health clinics


USFDA approves Phase 3 Acute Respiratory Distress Syndrome (ARDS), trial
Biotech | April 22, 2022

USFDA approves Phase 3 Acute Respiratory Distress Syndrome (ARDS), trial

The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the USFDA for an EV therapeutic


USFDA grants priority review to Roche’s Actemra/RoActemra to treat Covid-19
News | April 04, 2022

USFDA grants priority review to Roche’s Actemra/RoActemra to treat Covid-19

If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients


USFDA approves Yescarta as first CAR T-cell therapy for Lymphoma
Biotech | April 03, 2022

USFDA approves Yescarta as first CAR T-cell therapy for Lymphoma

Yescarta is First CAR T-cell therapy to receive NCCN treatment guideline category 1 recommendation --


Ozempic 2.0 mg approved in the US for the treatment of type 2 diabetes
Drug Approval | March 29, 2022

Ozempic 2.0 mg approved in the US for the treatment of type 2 diabetes

Ozempic is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults


Merck’s Keytruda approved for fourth gynecologic cancer indication
Drug Approval | March 22, 2022

Merck’s Keytruda approved for fourth gynecologic cancer indication

The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial


Glenmark receives ANDA approval for Lacosamide tablets
Drug Approval | March 21, 2022

Glenmark receives ANDA approval for Lacosamide tablets

The company plans to launch the product immediately


USFDA approves Rinvoq for ulcerative colitis
Drug Approval | March 17, 2022

USFDA approves Rinvoq for ulcerative colitis

First approved in 2019, Rinvoq is a JAK inhibitor approved for four indications across gastroenterology, dermatology and rheumatology


I Peace triples GMP cell manufacturing by expanding CDMO facility
Biotech | March 15, 2022

I Peace triples GMP cell manufacturing by expanding CDMO facility

The facility registration, along with DMF registration and GMP certification provides peace of mind to clients looking to use our iPSCs for clinical and commercial use in the United States, Japan, and other global markets