Pharmafile Logo
Pharmafocus logo
Advanced Search

FDA

Showing 15 posts of 1442 posts found.

allergan

FDA approves Allergan hypertension fixed-dose combo, Byvalson

June 7, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Allergan, FDA, US, angiotensin ii, approval, beta blocker, byvalson, hypertension, nebivolol, valsartan

Allergan has announced that the US Food and Drug Administration (FDA) has approved its fixed-dose combination, Byvalson (nebivolol and valsartan), …

News

New FDA expanded access guidelines spell trouble for Sarepta

June 2, 2016
Medical Communications, Research and Development, Sales and Marketing Duchenne Muscular Dystrophy, Eteplirsen, FDA, compassionate grounds, sarepta

New guidelines intended to streamline the process of expanded access to medicines by the US Food and Drug Administration (FDA) …

News

Biomarin withdraws regulatory submissions for Duchenne muscular dystrophy drug

June 1, 2016
Research and Development, Sales and Marketing BioMarin, Duchenne Muscular Dystrophy, EMA, FDA, Kyndrisa, failure, rejection

Biomarin (NASDAQ: BMRN) has announced that it has withdrawn its marketing authorisation application for Duchenne muscular dystrophy drug, Kyndrisa (drisapersen), …

News

FDA approves Lilly/Boehringer Ingelheim type-2 diabetes drug

June 1, 2016
Research and Development, Sales and Marketing Boehringer Ingelheim, Eli Lilly, FDA, diabetes, jentadueto, jentadueto xr, lilly, partnership, type 2, type-2

The US Food and Drug Administration (FDA) has approved Jentadueto XR (linagliptin and metformin hydrochloride extended release) tablets for the …

News
janssen_latest_logo_on_sign

Genmab receives milestone payment for first Darzalex sale in Europe

May 31, 2016
Manufacturing and Production, Sales and Marketing EU, FDA, Janssen, commercial, commercialised, daratumumab, darzalex, genman, multiple myeloma, sale, sales

Genmab (NASDAQ: GEN) has announced that the company is set to receive a milestone payment of $30 million from its …

News

FDA approves first buprenorphine implant for opioid dependence

May 27, 2016
Medical Communications, Sales and Marketing FDA, addiction, buprenorphine, dependence, implant, opioid, probuphine

The US Food and Drug Administration (FDA) has approved Probuphine, which is the first buprenorphine implant for the maintenance treatment …

News
lab

Shares at Sarepta Therapeutics jump after FDA delay in drug approval review

May 26, 2016
Research and Development, Sales and Marketing Duchenne Muscular Dystrophy, FDA, Sarepta Therapeutics, approval, delay, delayed announcement, muscular dystrophy, sarepta, treatment

Sarepta Therapeutics (NASDAQ: SRPT) has witnessed a sharp rise in the price of its shares after the US Food and …

News
novo_flag

FDA committee unanimously recommends Novo Nordisk diabetes combo, IDegLira

May 25, 2016
Research and Development, Sales and Marketing FDA, Novo Nordisk, Panel, Tresiba, Victoza, committee, ideglira, recommendation, staff

Novo Nordisk has announced that a US Food and Drug Administration (FDA) advisory committee has unanimously recommended IDegLira, a type-2 …

News
needles

CSL’s flu vaccine scores FDA approval

May 24, 2016
Manufacturing and Production, Research and Development, Sales and Marketing CSL, FDA, Vaccine, flu, four strain, four-strain, influenza, influenza a, influenza b, seqirus

Seqirus, a division of CSL, has announced that the US Food and Drug Administration (FDA) has approved Flucelvax Quadrivalent (influenza …

News
clinical_trial_3

Celator receives FDA breakthrough therapy designation for leukaemia drug

May 20, 2016
Medical Communications, Research and Development FDA, Vyxeos, acute myeloid leukaemia, breakthrough therapy, celator

A new treatment for acute myeloid leukaemia and other blood cancers from Celator Pharmaceuticals (NASDAQ: CPXX) has been granted breakthrough …

News
rocheshanghai

FDA grants accelerated approval for Roche’s bladder cancer immunotherapy Tecentriq

May 19, 2016
Research and Development, Sales and Marketing FDA, Roche, atezolizumab, bladder cancer, immunotherapy, tecentriq

Roche (SIX: RO) has announced that the US Food and Drug Administration (FDA) has granted accelerated approval for Tecentriq (atezolizumab) …

News
allergan

Allergan’s chronic eye disease treatment meets endpoints in pivotal trials

May 17, 2016
Manufacturing and Production, Sales and Marketing Allergan, FDA, chronic eye disease

Allergan has announced positive top line results from two pivotal late-stage trials for the first and only neurostimulation device for …

News
pfizerbrussels

Pfizer to acquire Anacor in $5.2 billion deal

May 16, 2016
Manufacturing and Production, Sales and Marketing 5.2 billion, FDA, Pfizer, acquisition, anacor, crisaborole, merger

Pfizer (NYSE: PFE) has acquired Anacor Pharmaceuticals (NASDAQ: ANAC) in a deal worth around $5.2 billion, or $99.25 per share. …

News
lilly_entrance_web

FDA issues warning about rare, but serious, side effect in Lilly antipsychotic drug

May 12, 2016
Medical Communications, Sales and Marketing Eli Lilly, FDA, anti-psychotic, boxed warning, lilly, olanzapine, skin condition

The US Food and Drug Administration (FDA) has issued a new warning to all drug labels for Eli Lilly’s antipsychotic …

News
fda2outsideweb

FDA expands Imbruvica label with new survival data

May 11, 2016
Research and Development, Sales and Marketing AbbVie, FDA, Janssen, data, efficacy, expanded, imbruvica, label, late stage, phase III

The US Food and Drug Administration (FDA) has expanded the label of Imbruvica (ibrutinib) to include the data from recent …

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