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Showing 15 posts of 23 posts found.

FDA accepts NDA for Karuna’s schizophrenia treatment

November 30, 2023
Medical Communications FDA, Karuna Therapeutics, NDA, Neurology, schizophrenia

Karuna Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for …

News

FDA accepts Sun Pharma’s NDA for deuruxolitinib

October 6, 2023
Medical Communications Dermatology, FDA, NDA, SUun Pharma, deuruxolitinib

India-based pharma company Sun Pharmaceutical Industries has announced that the US Food and Drug Administration (FDA) has accepted its New …

News

Bristol Myers Squibb’s NDA accepted by FDA

May 31, 2023
Medical Communications FDA, NDA, NSCLC, Oncology, bristol myers squibb

Global pharmaceutical company Bristol Myers Squibb (BMS) has announced that its New Drug Application (NDA) has been accepted by the …

News

FDA accepts Ipsen’s NDA for ultra-rare genetic disorder drug

June 1, 2021
Manufacturing and Production EMA, FDA, FOP, NDA, ipsen

The FDA have accepted Ipsen’s New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARγ agonist for the prevention …

News

Partnership with payers: Communicating and negotiating with impact

December 6, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing NDA, market access, pharma

NDA’s Lisa Peluso, Director, Coaching and Client Engagement, outlines key strategies for interacting with audiences and payers while maximising team …

News

Interactions with the Agencies During Drug Development

April 25, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Cambridge, NDA, drug development

 NDA would like to invite you to join  Professor Steffen Thirstrup, Director NDA Advisory Board, formerly Division Head at the Danish Medicines …

News
Press release

Europe vs USA: New drug approvals

June 1, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing NDA, regulatory affairs

Dr Terese Johansson, Regulatory Affairs Consultant NDA Group AB, examines the drop in US approvals while observing no similar trend …

Feature
White paper
fdaoutsideweb

FDA new drug approvals sink to six year low

December 21, 2016
Medical Communications, Research and Development FDA, NDA, new drug approvals

The FDA has released figures to show that drug approvals have fallen from last year’s high of 45 new drugs …

News
celgene_1_02

Celgene and Agios to file FDA application for “first-in-class” cancer drug

September 8, 2016
Research and Development, Sales and Marketing Celgene, FDA, NDA, acute myeloid leukaemia, agios

According to an SEC 8-K filing by Agios, the company and its partner Celgene intend to file a new drug …

News
sanofi_multaq

FDA delays appraisal of Sanofi, Zealand diabetes drug just days before decision due

August 22, 2016
Research and Development, Sales and Marketing NDA, Sanofi, appraisal, diabetes, iglarlixi, type 2, type-2, zealand

There was unfortunate news for Sanofi and Zealand Pharma as the FDA announced that it required additional information, constituting a …

News
gwpharma

GW Pharmaceuticals says Phase III trials for Epidiolex to treat rare epilepsy in children shows positive results

June 27, 2016
Research and Development, Sales and Marketing Epidiolex, GW Pharmaceuticals, NDA, US FDA, drug trial, orphan drug

GW Pharmaceuticals (Nasdaq: GWPH) said late-stage trials for its Epidiolex (cannabidiol or CBD) to treat Lennox-Gastaut syndrome (LGS), a rare …

News

AstraZeneca says NDA for drug to treat hyperkalaemia gets observations from the US FDA

May 27, 2016
Medical Communications, Research and Development AstraZeneca, NDA, US FDA, regulation

UK pharma firm AstraZeneca (LSE: AZN) on Friday said the US Food and Drug Administration (FDA) has issued a complete …

News
eli_lilly_logo

Lilly awaits FDA review of new arthritis treatment

January 20, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Eli Lilly, FDA, Incyte, NDA, baricitinib, lilly, new drug application, rheumatoid arthritis

Eli Lilly has submitted a new drug application (NDA) to the FDA for baricitinib as a treatment for moderate-to-severe rheumatoid …

News
Novolog pen

Novo Nordisk files for new insulin approval

December 10, 2015
Manufacturing and Production, Research and Development, Sales and Marketing FDA, NDA, Novo Nordisk, NovoLog, diabetes, insulin aspart, new drug application

Novo Nordisk has submitted a New Drug Application (NDA) for faster-acting insulin aspart to the FDA. If successful, the Danish …

News
onglyza

FDA rejects AstraZeneca diabetes combination

October 16, 2015
Research and Development, Sales and Marketing AstraZeneca, FDA, NDA, dapagliflozin, saxagliptin

The FDA has declined to approve AstraZeneca’s New Drug Application (NDA) for the investigational fixed-dose combination of Onglyza and and …

News

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