NDA
NDA in China receives priority review status for lung cancer treatment
January 3, 2025Research and Development China, China National Medical products Administration, HUTCHMED, NDA, Oncology, epidermal growth factor receptor, non-small cell lung cancer, priority review
HUTCHMED have announced that the China National Medical Products Administration (NMPA) have granted a priority review for a new drug …
FDA accepts NDA for Karuna’s schizophrenia treatment
November 30, 2023Medical 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 …
FDA accepts Sun Pharma’s NDA for deuruxolitinib
October 6, 2023Medical 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 …
Bristol Myers Squibb’s NDA accepted by FDA
May 31, 2023Medical 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 …
FDA accepts Ipsen’s NDA for ultra-rare genetic disorder drug
June 1, 2021Manufacturing 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 …
Partnership with payers: Communicating and negotiating with impact
December 6, 2019Business 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 …
Interactions with the Agencies During Drug Development
April 25, 2019Business 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 …
Europe vs USA: New drug approvals
June 1, 2017Business 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 …
FDA new drug approvals sink to six year low
December 21, 2016Medical 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 …
Celgene and Agios to file FDA application for “first-in-class” cancer drug
September 8, 2016Research 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 …
FDA delays appraisal of Sanofi, Zealand diabetes drug just days before decision due
August 22, 2016Research 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 …
GW Pharmaceuticals says Phase III trials for Epidiolex to treat rare epilepsy in children shows positive results
June 27, 2016Research 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 …
AstraZeneca says NDA for drug to treat hyperkalaemia gets observations from the US FDA
May 27, 2016Medical 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 …
Lilly awaits FDA review of new arthritis treatment
January 20, 2016Manufacturing 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 …
Novo Nordisk files for new insulin approval
December 10, 2015Manufacturing 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 …
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Santen joins inaugural Global Summit for Eye Health as partner
