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Valeant begins long comeback trail with FDA approval pharmafile
November 07, 2017
Valeant has had precious little to be happy about over the last few years, it’s bounced from one piece of bad news to another; however, it has managed a rare piece of good news after the FDA finally gave the green light for its glaucoma drug, Vyzulta.
Janssen Biotech submits NDA to FDA for apalutamide to treat non-metastatic CRPC pharmaceufical-technology
October 13, 2017
Apalutamide is a new investigational, oral androgen receptor (AR) inhibitor that inhibits the action of testosterone in prostate cancer cells and works by preventing androgen from binding to the androgen receptor.
Samsung BioLogics Receives the 1st FDA Approval at the World's Largest Plant prnasia
October 12, 2017
With the first license of its second plant from the FDA, Samsung BioLogics is now able to manufacture commercial Biologics Drug Substance at its second plant in addition to its first plant which has 30,000 liters of capacity.
Lupin receives FDA approval for generic Corgard Tablets expressbpd
October 10, 2017
Nadolol Tablets are indicated for management of patients with angina pectoris and for the treatment of hypertension
Looking for insulin rebound, Novo Nordisk wins delayed FDA nod for ultrafast Fiasp fiercepharma
September 30, 2017
For Novo Nordisk and its new fast-acting mealtime insulin, a second try at the FDA gatekeepers was enough to secure an approval.
Medtronic bags expanded FDA OK for heart failure pump fiercebiotech
September 30, 2017
The FDA approved Medtronic’s HeartWare implantable heart failure pump as a destination therapy for heart failure patients who are not candidates for a heart transplant.
Lupin receives FDA approval for generic Clobex lotion expressbpd
September 27, 2017
It is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations
Merck’s Keytruda receives accelerated FDA approval for GEJ adenocarcinoma pharmaceufical-technology
September 26, 2017
Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that increases the ability of the patient’s immune system to help detect and combat tumour cells.
FDA approves first medical app, for use in addiction pharmafile
September 19, 2017
The FDA has taken a major step in the digitisation of healthcare by handing out the first medical app approval: the reSET app for substance use disorder, created by Pear Therapeutics.
Amgen and Allergan win FDA nod for biosimilar of Avastin, Roche's $3B seller fiercepharma
September 15, 2017
The FDA has ushered in a new era in lower cost cancer medicines with its approval of Amgen’s and Allergan's Mvasi, a biosimilar of Roche’s blockbuster drug Avastin.

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