Pharmafile Logo
Pharmafocus logo
Advanced Search

FDA

Showing 15 posts of 1442 posts found.

Cyramza image

Lilly’s lung cancer drug sees FDA approval

December 17, 2014
Sales and Marketing BMS, Cancer, FDA, NSCLC, cyramza, docetaxel, lilly, opdivo, ramucirumab

Eli Lilly’s lung cancer drug Cyramza (ramucirumab) has been shown the green light by the US Food and Drug Administration …

News
Signifor image

Novartis hormone disorder drug approved in US

December 16, 2014
Sales and Marketing FDA, Lar, Signifor, acromegaly, cushing, hormone, pasireotide

The FDA has approved Novartis’ Signifor (pasireotide) for the treatment of a rare and life-threatening hormonal disorder. The US Food …

News
Zelboraf image

Roche submits melanoma drug to FDA

December 15, 2014
Sales and Marketing Cobimeinib, FDA, Roche, Zelboraf, mekinist, melanoma, taflinlar, vemurafenib

Roche has submitted its melanoma drug cobimeinib for review with the FDA as it confirms the results of its Phase …

News
Ranbaxy image

Ranbaxy and Sun Pharma merger approved

December 9, 2014
Manufacturing and Production, Sales and Marketing FDA, Ranbaxy, Sun Pharma, cci, tamsulosin, tolterodine

The Competition Commission of India (CCI) has approved Sun Pharma’s acquisition of struggling drugmaker Ranbaxy, subject to conditions designed to …

News
GSK image

GSK cancels sale of established products

December 5, 2014
Medical Communications, Sales and Marketing FDA, GSK, Paxil, Seroxat, Zantac, bribery, cuts, imitrex

GlaxoSmithKline has decided not to sell off several of its ageing brands in the face of continuing business problems. The …

News
Ranbaxy image

Ranbaxy launches J&J biosimilar in India

December 5, 2014
Manufacturing and Production, Sales and Marketing CHMP, FDA, India, J&J, JJ, Ranbaxy, Remicade, nlem, nppa

Ranbaxy has launched the first biosimilar of Johnson & Johnson’s Remicade (infliximab) in India, marking the firm’s entry into monoclonal …

News
Amgen image

Speedy FDA nod for Amgen leukaemia drug

December 5, 2014
Research and Development, Sales and Marketing B-cell lymphoblasts, FDA, Kyprolis, blinatumomab, blincyto, leukaemia

The FDA has approved Amgen’s Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukaemia (B-cell ALL). …

News
23andMe genome testing kit image

MHRA approves Google gene test for UK

December 2, 2014
Medical Communications, Research and Development, Sales and Marketing 23andME, DNA, FDA, MHRA, UK, US, gene, google, test

The MHRA has approved a controversial genetic test for the UK – despite it being banned by the US FDA. …

News
FDA image

FDA clears Sanofi TB drug indication

December 2, 2014
Research and Development, Sales and Marketing Bedaquiline, FDA, Sanofi, WHO, priftin, rifapentine, sirturo

The FDA has approved Sanofi’s Priftin for a new tuberculosis (TB) indication following a priority review from the regulator. Priftin …

News

Priority review for Novartis myeloma drug

November 26, 2014
Sales and Marketing FDA, Farydak, Novartis, daratumumab, elotuzumab, myeloma, odac

Novartis’ multiple myeloma treatment Farydak has been given an extended review by the FDA after its future seemed in jeopardy …

News
BI image

CHMP nods several drugs through

November 24, 2014
Sales and Marketing Boehringer, CHMP, EMA, Esbriet, FDA, Sanofi, nintedanib, ofev

Ten new medicines have been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP), among …

News

Future bleak for Novartis’ myeloma drug

November 21, 2014
Medical Communications FDA, Farydak, Novartis, ixazomib, myeloma, panobinostat

Novartis suffered a major disappointment with the negative FDA panel vote for multiple myeloma candidate Farydak earlier this month, but …

News
Genzyme image

FDA green lights Lemtrada for MS

November 17, 2014
Sales and Marketing FDA, Genzyme, Lemtrada, MS, Sanofi, rems, tecfidera

The US FDA has approved Sanofi’s Lemtrada for multiple sclerosis, almost a year after rejecting the drug on concerns about …

News
FDA image

FDA decides on format for facility registrations

November 11, 2014
Manufacturing and Production FDA, fdasia, gln, gs1, manufacturing, ufi

The US FDA has finalised the details of its registration scheme for pharma manufacturing facilities, which aims to make it …

News
BMS image

BMS lung cancer drug scores in Phase II

October 31, 2014
Sales and Marketing BMS, Bristol-Myers Squibb, Cancer, FDA, NSCLC, bristol myers-squibb, odivo

Bristol-Myers Squibb is still in the hunt to gain significant market share in the PD-1 therapeutic vaccine race after releasing …

News
The Gateway to Local Adoption Series

Latest content

Just – Evotec given Gates Foundation grant to increase global biotherapeutics access

January 8, 2026

Johnson & Johnson submits robotic surgical system for De Novo classification

January 8, 2026

EA Pharma announces phase 3 trial for new schizophrenia treatment in Japan

January 7, 2026

Eleva appoints Erich Rajkovic as Chief Business Officer

January 7, 2026

MedPharm announces US FDA inspection of North Carolina manufacturing facility

January 6, 2026