Pharmafile Logo
Pharmafocus logo
Advanced Search

FDA

Showing 15 posts of 1442 posts found.

Roche granted further good news by FDA

October 11, 2016
Manufacturing and Production Actembra, Alecensa, FDA, Lucentis, Roche, United States, america

Roche was given further good news by FDA after receiving a Priority Review for its Lucentis drug – this news …

News
fda_sign_web

FDA warns that certain hepatitis C drugs can have serious side-effects

October 5, 2016
Medical Communications, Research and Development FDA, hepatitis B, hepatitis C

The FDA has issued a warning to patients who are currently taking drugs to treat hepatitis C that they may …

News

Roche granted breakthrough therapy designation by FDA

October 5, 2016
Research and Development Actemra, FDA, Giant Cell arteritis, Roche, breakthrough therapy

Roche has announced that the FDA has granted its Actembra drug breakthrough therapy designation for giant cell arteritis. The breakthrough …

News
jj_2johnson_and_johnson

Patients’ insulin pumps are revealed to be hackable by J&J

October 4, 2016
Research and Development, Sales and Marketing FDA, Hackers, Johnson & Johnson, diabetes, insulin

Johnson & Johnson have begun warning patients that their insulin pumps, that patients attach to their bodies and are controlled …

News
roche_side_building

Roche’s Alecensa receives second FDA Breakthrough Therapy Designation

October 4, 2016
Manufacturing and Production ALK+, Alecensa, FDA, Roche, alk, crizotinib

Alecensa has been designated as a breakthrough therapy, which will speed up the process towards FDA approval, should clinical trials …

News
biogen_austria_238

Biogen closes in on bringing muscular atrophy preventing drug to market

September 26, 2016
Manufacturing and Production, Research and Development Biogen, EMA, FDA, Nusinersen

Biogen has applied for Priority Review, which, if granted, would shorten the review period necessary for nusinersen. They also plan …

News
humira_abbott__4

FDA gives the green light to the first Humira biosimilar

September 26, 2016
Sales and Marketing AbbVie, Amgen, Amjevita, FDA, Humira

Amgen’s Amjevita has been given the go ahead for all eligible indications of its reference product, including moderate-to-severe rheumatoid arthritis, …

News

Duchenne drug gets FDA approval in “unprecedented” ruling

September 20, 2016
Manufacturing and Production, Sales and Marketing Duchenne Muscular Dystrophy, FDA, sarepta

The FDA has gone against the advice of its own staff to approve the first treatment of Duchenne muscular dystrophy …

News
hero-plus

Mylan CEO to appear before US congress over EpiPen scandal

September 15, 2016
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Hilary Clinton, Mylan, epipen

Following the controversy of Mylan’s price increases to its EpiPen (epinephrine) auto-injector, the company’s CEO Heather Bresch is due to …

News
sanofi_hq__boetie_hall

Sanofi reveals promising data for FDA-delayed diabetes drug

September 14, 2016
Research and Development, Sales and Marketing FDA, Lantus, Sanofi, iglarlixi

Sanofi has announced new Phase III data for its IGlarLixi combination drug for the treatment of diabetes, showing it could …

News
4420456374_64a3d7e6aa

Top ten stories in the pharmaceutical industry this week

September 9, 2016
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing ABPI, AstraZeneca, BMS, Celgene, Cloud Computing, Eisai, FDA, GSK, Halaven, Novartis, Novo Nordisk, Roche, Teva, agios, epipen, rheumatoid arthritis

It’s Friday, and that means it’s time for another run-down of the biggest stories on Pharmafile.com over the last week. …

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
merck_and_co

FDA to review MSD’s Keytruda as a first-line lung cancer treatment

September 7, 2016
Research and Development FDA, MSD, Merck, first-line, keytruda, lung cancer, non-small cell lung cancer, opdivo

The US Food and Drug Administration has accepted the supplemental biologics license application from MSD, known as Merck in the …

News

FDA fast track designation for Biogen’s investigational Alzheimer’s treatment

September 2, 2016
Medical Communications, Research and Development Alzheimer's, Alzheimer’s, Biogen, FDA, aducanumab, fast track

Biogen has announced that its investigational Alzheimer’s disease treatment aducanumab has been granted fast track designation by the FDA. The …

News
amgen_flag

Amgen’s leukaemia treatment given FDA thumbs up for use in paediatric patients

September 2, 2016
Medical Communications, Sales and Marketing Amgen, FDA, blincyto, leukaemia

Amgen has announced that the FDA has approved the supplemental Biologics License Application for Blincyto (blinatumomab) in the treatment of …

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