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406 News Found

Cyprium Therapeutics and Sentynl, a Zydus subsidiary announce positive data for CUTX-101, CuHis
Biotech | October 09, 2021

Cyprium Therapeutics and Sentynl, a Zydus subsidiary announce positive data for CUTX-101, CuHis

The rolling submission to the U.S. FDA will begin in the fourth quarter of this year


EMA authorises booster dose of Moderna’s Spikevax
Drug Approval | October 06, 2021

EMA authorises booster dose of Moderna’s Spikevax

A growing number of studies have shown the benefit of a third dose of Covid-19 vaccine in immunocompromised subjects


Jubilant concludes pre-IND meeting of JB1-802 with U.S. FDA
Biotech | October 01, 2021

Jubilant concludes pre-IND meeting of JB1-802 with U.S. FDA

The company plans to submit the IND application by the end of 2021


WHO new Essential Medicines Lists focus on diabetes and cancer
Public Health | September 30, 2021

WHO new Essential Medicines Lists focus on diabetes and cancer

The listings aim to address global health priorities, identifying the medicines that provide the greatest benefits, and which should be available and affordable for all


DCGI approves Ampio Pharma’s Phase II trials to tackle Covid-19 induced respiratory distress
Biotech | September 22, 2021

DCGI approves Ampio Pharma’s Phase II trials to tackle Covid-19 induced respiratory distress

Ampion is directly administered by inhalation and it allows the drug to directly target and attenuate inflammation in the lungs


Imfinzi plus chemotherapy tripled patient survival at 3 years
Biotech | September 20, 2021

Imfinzi plus chemotherapy tripled patient survival at 3 years

The CASPIAN Phase III trial in extensive-stage small-cell lung cancer is the longest survival follow-up ever reported for immunotherapy treatment in this setting


Roche receives positive CHMP opinion for Gavreto
Drug Approval | September 18, 2021

Roche receives positive CHMP opinion for Gavreto

If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC


U.S. FDA approves Thermo Fisher Scientific’s Oncomine Dx target test
Medical Device | September 16, 2021

U.S. FDA approves Thermo Fisher Scientific’s Oncomine Dx target test

It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations


Pfizer announces Phase 3 clinical trial for vaccine against Respiratory Syncytial Virus (RSV)
Drug Approval | September 03, 2021

Pfizer announces Phase 3 clinical trial for vaccine against Respiratory Syncytial Virus (RSV)

RSV is a common and pervasive cause of severe acute respiratory illness in older adults with no vaccine currently available


US FDA clears InnoCare’s clinical trial of pan-TRK Inhibitor ICP-723
Drug Approval | August 31, 2021

US FDA clears InnoCare’s clinical trial of pan-TRK Inhibitor ICP-723

The clinical trial will evaluate the safety, tolerability and pharmacokinetic properties of ICP-723 in patients with solid tumours, and evaluate the anti-tumour efficacy of ICP-723 on NTRK fusion-positive cancers