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Showing 15 posts of 1442 posts found.

fda

FDA approves Takeda’s first-line treatment option for non-small cell lung cancer

May 26, 2020
Manufacturing and Production FDA, Takeda, approval

The FDA has approved Takeda’s Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer …

News
clinical_study

Genfit’s NASH drug fails Phase 3 clinical trial

May 12, 2020
Manufacturing and Production FDA, nash

The Phase 3 trial for Genfit’s drug elafibranor has failed to improve outcomes for patients with the fatty liver disease …

News
fda

FDA provides new guidelines to accelerate the development of COVID-19 treatments

May 12, 2020
Manufacturing and Production COVID-19, FDA, coronavirus, pandemic

The FDA has provided new guidelines to researchers studying potential COVID-19 treatments to help speed up the process of their …

News
fda2outsideweb

AZ’s Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction

May 6, 2020
Research and Development, Sales and Marketing AstraZeneca, FDA, farxiga, heart failure

The FDA has moved to approve an oral tablet formulation of AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of cardiovascular …

News
gilead-sciences

FDA approves emergency use of Gilead’s remdesivir for hospitalised COVID-19 patients

May 4, 2020
Sales and Marketing COVID-19, FDA, Gilead, coronavirus, remdesivir

Gilead’s antiviral therapy remdesivir has shown tentatively promising efficacy in the race to find an effective treatment for COVID-19, one …

News

Sanofi’s Meningococcal Conjugate Vaccine secures FDA approval in patients aged two and up

April 27, 2020
Sales and Marketing FDA, MenQuadfi, Sanofi, US, meningococcal disease, pharma

Sanofi’s MedQuadfi Meningococcal Conjugate Vaccine has scored FDA approval for the prevention of invasive meningococcal disease, becoming the first and …

News
images_1

FDA urges close monitoring of COVID-19 patients treated with hydroxychloroquine

April 27, 2020
Sales and Marketing COVID-19, FDA, chloroquine, coronavirus, hydroxychloroquine

The FDA has released a safety communication reiterating the need for doctors to closely monitor COVID-19 patients who are treated …

News
fda

Cheaper Canadian drug imports continue to be seized by the FDA

April 23, 2020
Business Services COVID-19, Canada, FDA, coronavirus, insulin

Seizures of Canadian drugs being sent to American patients have been stepped up by the FDA. This is according to …

News
abbvie_0

AbbVie’s Imbruvica scoops up 11th FDA approval with chronic lymphocytic leukaemia/small lymphocytic lymphoma nod

April 22, 2020
Research and Development, Sales and Marketing Cancer, FDA, imbruvica, leukaemia

AbbVie’s Imbruvica (ibrutinib) has scored its 11th FDA approval, this time in combination with rituximab for the treatment of chronic …

News
stock-incyte-01-shutter

Incyte’s Pemazyre becomes FDA’s first and only approved unresectable, advanced cholangiocarcinoma treatment

April 20, 2020
Sales and Marketing FDA, Incyte, pharma

The FDA has approved the United States’ first and only treatment for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma, …

News
fda

FDA cautions that drug reviews will be slower due to COVID-19

April 17, 2020
Medical Communications COVID-19, FDA, coronavirus

The FDA has warned that they may not be able to sustain its current levels of timely reviews and approvals …

News
fda2outsideweb

FDA approves UroGen’s Jelmyto as first therapy for low-grade upper tract urothelial cancer

April 16, 2020
Sales and Marketing Cancer, FDA, Jelmyto, UroGen Pharma, pharma, urothelial cancer

The FDA has moved to authorise UroGen Pharma’s Jelmyto (mitomycin gel) in the US for the treatment of low-grade upper …

News
fda2outsideweb

FDA approval for BMS and Acceleron’s Reblozyl to reduce red blood cell transfusion dependence

April 6, 2020
Manufacturing and Production, Sales and Marketing BMS, FDA, Reblozyl, pharma

The FDA has given the regulatory thumbs-up in the US of Reblozyl (luspatercept-aamt), the “first and only erythroid maturation agent” …

News
0000_hearttt

FDA calls for heartburn drug Zantac to be pulled due to carcinogen concerns

April 2, 2020
Business Services FDA, NDMA, Sanofi, heartburn

The FDA is requesting that manufactures remove Zantac (ranitidine) from the market due to risks of it containing a carcinogen. …

News
blood-75301_1280

US approval for haemophilia drug derived from genetically engineered rabbit’s milk

April 2, 2020
Sales and Marketing FDA, US, haemophilia, pharma

The FDA has announced the approval of Sevenfact, a haemophilia therapy the active ingredient from which is expressed in genetically …

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