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Results For "small-cell-lung-cancer"

137 News Found

Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review
Biotech | March 01, 2022

Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review

If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.


Innovent Biologics and AnHeart Therapeutics receive NMPA breakthrough designation for taletrectinib
Biotech | March 01, 2022

Innovent Biologics and AnHeart Therapeutics receive NMPA breakthrough designation for taletrectinib

The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors


USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib
Drug Approval | February 18, 2022

USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib

The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022


USFDA approves IND application for Allied’s cancer treatment
Biotech | January 24, 2022

USFDA approves IND application for Allied’s cancer treatment

APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types


Jubiant Therapeutics gets USFDA clearance for JBI-802 to treat solid tumours
Biotech | January 07, 2022

Jubiant Therapeutics gets USFDA clearance for JBI-802 to treat solid tumours

JBI-802 is a novel, oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6


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


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


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


European Commission approves Roche’s Gavreto
Drug Approval | November 22, 2021

European Commission approves Roche’s Gavreto

Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people with RET fusion-positive advanced NSCLC


Merck showcases potential for several cancers, MS and lupus
News | November 22, 2021

Merck showcases potential for several cancers, MS and lupus

Five potential first-in-class assets aimed at delivering significant long-term growth. Over 14 clinical development programs underway across portfolio and 11 new studies to start in 2022 across early- and late-stage pipeline