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Showing 15 posts of 1444 posts found.

Akari Therapeutics open IND with FDA for bullous pemphigoid treatment

April 13, 2021
Manufacturing and Production FDA

Akari Therapeutics have opened an investigational new drug application (IND) with the FDA for its multicentre Phase III study with …

News

Immutep achieves FDA Fast Track designation for soluble LAG-3 protein

April 12, 2021
Sales and Marketing FDA, HNSCC

Immutep, a biotechnology company developing novel immunotherapy treatments for cancer, infectious disease, and autoimmune disease, has achieved FDA Fast Track …

News
Gilead sign

FDA approve Gilead’s breast cancer treatment after Phase III trial

April 8, 2021
FDA, Gilead, Trodelvy, pharma, pharma news

The FDA has approved Gilead’s Trodelvy therapy for the treatment of metastatic triple-negative breast cancer (TNBC).

News

FDA approves first new ADHD drug in a decade

April 6, 2021
Manufacturing and Production ADHD, FDA, paediatric

The FDA have approved the first new drug for the treatment of attention deficit hyperactivity disorder (ADHD) in over a …

News

New Sanofi Sarclisa treatment for multiple myeloma approved by FDA

April 1, 2021
FDA, FDA Approval, Sanofi, Sarclisa, multiple myeloma

Sanofi’s Sarclisa drug has been approved by the FDA in combination with carfilzomib and dexamethasone (Kd) for the treatment of …

News

BD’s rapid COVID-19 test granted Emergency Use Authorization by FDA

April 1, 2021
BD, COVID-19, COVID-19 testing, EUA, FDA

The FDA has granted Emergency Use Authorization (EUA) for Becton, Dickinson and Company’s (BD) rapid antigen test to be used …

News
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The Truth Behind the £1.8 Million Drug

March 31, 2021
Manufacturing and Production FDA, NHS, NICE

As NICE approves the most expensive drug ever for use by the NHS, Jack Goddard takes a look at drug …

Feature

Amryt submits NDA to the FDA for Oleogel-S10

March 31, 2021
Research and Development FDA

Amryt has today announced the rolling submission of a New Drug Application (NDA) to the FDA for Olegel-S10, potential treatment …

News

FDA approve Astellas’s Myrbetriq treatment for bladder dysfunction

March 26, 2021
Medical Communications Astellas Pharma, FDA, Ida approval

The FDA have approved a new indication for Astellas Pharma’s Myrbetriq and Myrbetriq Granules to treat neurogenic detrusor overactivity (NDO), …

News

Zealand’s Zegalogue treatment for hypoglycemia approved by FDA

March 23, 2021
Manufacturing and Production FDA, Zealand Pharma, Zegalogue

The FDA have approved Zealand Pharma’s Zegalogue therapy for the treatment of severe hypoglycemia in patients with diabetes.

News

FDA approves Kiniksa’s recurrent pericardis treatment ARCALYST

March 22, 2021
Sales and Marketing FDA

The FDA have approved ARCALYST (rilonacept) for the treatment and risk reduction of recurrent pericardis in adults and children over …

News
FDA building

FDA approves AVEO’s kidney cancer treatment

March 11, 2021
Aveo, FDA, Kidney cancer, fotivda, rcc

The FDA has approved AVEO Oncology’s FOTIVDA drug for the treatment of adults with relapsed or refractory advanced renal cell …

News
FDA building

FDA approves Kite’s Yescarta therapy for follicular lymphoma

March 9, 2021
Manufacturing and Production FDA, Kite, Yescarta

The FDA has granted accelerated approval to Kite’s Yescarta treatment, a medicine for adult patients with relapsed or refractory follicular …

News
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FDA grants Priority Review to Korsuva for CKD-associated pruritis

March 8, 2021
Sales and Marketing Cara Therapeutics, FDA, Korsuva

The FDA has accepted and granted Priority Review for the new drug application (NDA) for Cara Therapeutics’ Korsuva (difelikefalin) solution …

News
bluebird_bio_external_durham_nc_manufacturing

FDA halts studies for bluebird bio’s sickle cell therapy LentiGlobin

February 24, 2021
Research and Development Bluebird Bio, FDA, sickle cell disease

The FDA has put bluebird bio’s LentiGlobin gene therapy programme for sickle cell disease (SCD) on clinical hold, following Suspected …

News
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