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Avance Clinical at World Vaccine Congress to Share Latest Vaccine Clinical Trial News Including an HIV-1 Study

Lungershausen said Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III....
Mar 29

Moderna has announced that the Omicron vaccine has yielded positive results.

On Wednesday, Moderna, a biotech company based in the United States, announced positive results for a new vaccine that targets both the original Covid strain ...
Jun 09

GSK announces positive headline results from five Phase 3 studies of daprodustat for patients with anaemia

GSK plc today announced positive headline results from five studies of the Phase 3 ASCEND programme, for patients with anaemia due to chronic kidney disease (...
Jul 17

Koselugo approved in the EU for children with neurofibromatosis type 1 and plexiform neurofibromas

First medicine approved in the EU to treat this rare and debilitating genetic condition...
Jun 22

Novartis announces positive result of phase III study with radioligand therapy 177Lu-PSMA-617

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Mar 25

U.S. FDA expands approval of Pfizer’s LORBRENA as first-line treatment for ALK-Positive Metastatic Lung Cancer

In 2018, the FDA approved LORBRENA for the treatment of patients with ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least ...
Mar 05

GSK, MMV filing for Kozenis in paediatric populations with Plasmodium vivax malaria accepted by Australian Therapeutic Goods Administration

The application includes data for a new, 50 mg tablet that can be dispersed in water and which was developed to facilitate use in children, ...
Jan 08

Farxiga granted Priority Review in the US for the treatment of patients with chronic kidney disease

Farxiga could become the first SGLT2 inhibitor approved to treat patients with chronic kidney disease, with and without type-2 diabetes...
Jan 06

People need both doses of coronavirus vaccines - FDA

Pfizer or Moderna 2 doses are needed for effectiveness...
Jan 05

Pfizer's LORBRENA sNDA in previously untreated ALK-positive lung cancer accepted for priority review by U.S. FDA

LORBRENA is a third-generation ALK inhibitor specifically developed to inhibit the most common tumour mutations that drive resistance to current medications and to address ...
Dec 29

FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia

Today, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, ...
Dec 29

OraSure Technologies Provides Update on Its Emergency Use Authorization Application for Its Lab-based Oral Fluid SARS-CoV-2 Antibody Test

The OraSure SARS-CoV-2 Antibody ELISA is intended for the qualitative detection of total antibodies to SARS-CoV-2 in human oral fluid specimens ...
Dec 22

PFIZER AND BIONTECH ACHIEVE FIRST AUTHORIZATION IN THE WORLD FOR A VACCINE TO COMBAT COVID-19

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Dec 02

India becoming pharmacy of the world

As the world races to develop the vaccine for Covid-19, India is looking to be self-reliant in both its development and production....
Dec 01

Government Launches Mission COVID Suraksha to accelerate Indian COVID-19 Vaccine Development

Mission COVID Suraksha is the targeted effort to enable the development of indigenous, affordable and accessible vaccines for the country and will complement the National ...
Nov 30

Merck Submits Applications for Licensure of V114, the Company’s Investigational 15-valent Pneumococcal Conjugate Vaccine

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Nov 23

Bayer submits marketing authorization applications for finerenone in the U.S. and the EU

Finerenone for patients with chronic kidney disease and type 2 diabetes...
Nov 10

AbbVie submits regulatory applications to US FDA and EMA for RINVOQ (upadacitinib) in atopic dermatitis

These submissions are an important step forward in the commitment to providing an additional treatment option ...
Oct 20

Late-breaking ESMO presentation shows Libtayo® (cemiplimab) monotherapy increases overall survival in first-line advanced non-small cell lung cancer with PD-L1

Positive pivotal trial data for the investigational use of PD-1 inhibitor Libtayo® (cemiplimab) in first-line locally advanced or metastatic non-small cell lung ...
Sep 21

Regeneron announces FDA accepts evinacumab BLA for priority review as treatment for patients with HoFH

The FDA granted evinacumab breakthrough therapy designation in 2017 for the treatment of hypercholesterolemia in patients with HoFH...
Aug 13

Positive phase 3 data for atogepant in migraine prevention

AbbVie announced that the Phase 3 ADVANCE trial evaluating the investigational medicine atogepant in migraine prevention...
Jul 31

GSK receives first regulatory approval for Duvroq in Japan

Duvroq is a oral medicine indicated for the treatment of anaemia due to CKD in adult patients not on dialysis and on dialysis...
Jul 02

iNova Pharmaceuticals announces the launch of iPitch 2020

iNova Pharmaceuticals is a multinational pharmaceutical and health care company that sells a wide range of market-leading products...
Jun 26

Panacea Biotec and Refana announce landmark collaboration for COVID-19 vaccine

Panacea Biotec and Refana are targeting to manufacture 500 million COVID-19 vaccines over 12 months...
Jun 11

EU approves Bristol Myers Squibb’s Idecabtagene Vicleucel and CC-486

Finally Bristol Myers Squib receives approval from EU for Idecabtagene Vicleucel...
May 23

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