Pharmafile Logo
Pharmafocus logo
Advanced Search

FDA

Showing 15 posts of 1445 posts found.

4420456374_64a3d7e6aa

Top Ten most popular articles on Pharmafile.com this week

August 11, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Merck, NICE, Parkinson's, biotech, diabetes, pharma, pharmaceutical, top ten

Another week, another busy week in pharma. The last seven days have seen some remarkable strides in the diabetes space, …

News
shutterstock_38078521

FDA awards orphan status to new brain cancer vaccine

August 9, 2017
Research and Development, Sales and Marketing FDA, life sciences, orphan drug, pharma, pharmaceuticals

The FDA has announced that it has awarded orphan drug status to the vaccine SurVaxM for patients with glioblastoma, the …

News
janssen_latest_logo_on_sign

FDA turns down Janssen’s sirukumab for rheumatoid arthritis

August 3, 2017
Sales and Marketing FDA, Janssen, drugs, life sciences, medicine, pharma, pharmaceuticals, rheumatoid arthritis, sirukumab

Janssen has announced that it has suffered a knockback to its plans to commercialise sirukumab in the US in the …

News
astrazeneca_logo_building

AstraZeneca’s Priority Review good news provides reprieve

August 2, 2017
Sales and Marketing AstraZeneca, FDA, biotech, drugs, pharma, pharmaceutical

If there was a company that needed a series of good news stories this week, it was AstraZeneca. The blow …

News
celgene_1_02

FDA approves Celgene and Agios’ acute myeloid leukaemia drug

August 2, 2017
Research and Development, Sales and Marketing Celgene, FDA, Idhifa, acute myeloid leukaemia, agios, biotech, drugs, life sciences, medicines, pharma, pharmaceuticals

The FDA has given its approval for the commercialisation of Celgene and Agios Pharmaceutical’s Idhifa for the treatment of relapsed …

News
astrazeneca_building_white

AstraZeneca scores second accelerated FDA review in 2 days for blood cancer drug

August 1, 2017
Manufacturing and Production, Sales and Marketing AstraZeneca, FDA, acalabrutinib, biotech, drugs, life sciences, pharma, pharmaceutical

It’s been a rollercoaster week for AstraZeneca.

News

FDA Chief plans regulatory overhaul to tackle US opioid crisis

July 25, 2017
Manufacturing and Production, Sales and Marketing FDA, Scott Gottlieb, biotech, drugs, healthcare, opioid, pharma, pharmaceutical

The US faces an ongoing crisis in opioid dependency, and FDA Commissioner Scott Gottlieb is prepared to employ unusual tactics …

News
white_house_trump

Trump throws weight behind pharmaceutical manufacturing

July 21, 2017
Medical Communications, Sales and Marketing FDA, President trump, Trump, biotech, drugs, pharma, pharmaceutical

In a press conference at the White House, President Trump, alongside representatives from Corning, MSD and Pfizer, announced that 1,000 …

News
merck_and_co

MSD’s Lantus biosimilar given conditional FDA approval

July 21, 2017
Medical Communications, Sales and Marketing FDA, MSD, Sanofi, biosimilar, biotech, drugs, pharma, pharmaceutical

MSD, known as Merck in North America, has been granted approval for its biosimilar of Sanofi’s diabetes treatment, Lantus. Potentially, …

News
gilead-sciences

FDA gives approval for Gilead’s hepatitis C therapy

July 19, 2017
Research and Development, Sales and Marketing FDA, Gilead, US, Vosevi, biotech, drugs, healthcare, pharma, pharmaceutical

The FDA has announced that it has chosen to approve Vosevi (sofosbuvir/velpatasvir/voxilaprevir), Gilead’s investigational drug for the treatment of chronic …

News
document-428331_960_720

Independent panel advise FDA to apply different framework to opioid painkillers

July 14, 2017
Medical Communications FDA, biotech, drugs, opioid, opioid epidemic, pharma, pharmaceutical

Over a year ago, the Obama administration asked the National Academies of Sciences, Engineering, and Medicine to advise them on …

News

Novartis’ breakthrough cancer treatment receives FDA advisory approval

July 13, 2017
Research and Development, Sales and Marketing CAR-T, FDA, Novartis, biotech, drugs, pharma, pharmaceutical

In what could well be a game-changing decision for cancer treatment, the FDA advisory panel gave Novartis’ CAR-T Therapy, CTL019 …

News
fda2outsideweb

Plot twist as FDA U-turns on Amicus drug decision

July 11, 2017
Research and Development, Sales and Marketing Amicus Therapeutics, FDA, Galafold

The news continues to flow out of the FDA, as it grabs another headline by backtracking on its previous decision …

News

Endo withdraws product as FDA secures step in opioid crisis fightback

July 10, 2017
Sales and Marketing Endo pharmaceuticals, FDA, Opana ER

The FDA took the unusual step to ask Endo Pharmaceutical to voluntarily withdraw its opioid painkiller, Opana ER, from the …

News
eu_and_fda

EMA and FDA harmonise over development of Gaucher drugs

July 5, 2017
Medical Communications, Research and Development, Sales and Marketing EMA, FDA, Gaucher disease

The EMA and the FDA have announced that they have developed a joint proposal to promote more efficient means of …

News
The Gateway to Local Adoption Series

Latest content

Kayentis and RWS partner to improve clinical trial data confidence

April 17, 2026

MHRA expands its pioneering AI Airlock programme with £3.6m funding boost

April 16, 2026

Ardena opens new US bioanalytical laboratory

April 15, 2026

Gesynta Pharma doses first patient in endometriosis phase 2 trial

April 14, 2026

Astellas Pharma’s new non-hormonal menopausal hot flush treatment Veoza can be used in the NHS, NICE says

April 13, 2026