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17 September 2014 | By AstraZeneca
AstraZeneca announced that the US Food and Drug Administration approved MOVANTIK™ (naloxegol) tablets C-II as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain...
10 September 2014 | By Actavis
Actavis plc confirmed that the U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted to recommend against approval of Actavis' New Drug Application for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension...
27 August 2014 | By GlaxoSmithKline
GlaxoSmithKline plc announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for the once-daily use of Promacta® (eltrombopag) in patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy...
26 August 2014 | By Actavis
Actavis plc confirmed that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Rotigotine Extended-release Transdermal Film, 1 mg/24 hr, 2mg/24 hr, 3 mg/24hr, 4 mg/24 hr, 6mg/24hr, and 8 mg/24 hr...
26 August 2014 | By GlaxoSmithKline
ViiV Healthcare announced that the US Food and Drug Administration has approved Triumeq® (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection...
19 August 2014 | By Pfizer
Pfizer Inc. announced it has completed the submission of a New Drug Application (NDA) to the United States Food and Drug Administration for palbociclib...
18 August 2014 | By Biogen Idec
Biogen Idec announced that the U.S. Food and Drug Administration has approved PLEGRIDYTM (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis...
15 August 2014 | By Pfizer
Pfizer Inc. announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for bivalent recombinant LP2086...
14 August 2014 | By Amgen
Amgen initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp® (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies...
11 August 2014 | By Johnson & Johnson
Janssen Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration has approved INVOKAMET™, a fixed-dose therapy combining canagliflozin and metformin hydrochloride in a single tablet, for the treatment of adults with type 2 diabetes...
4 August 2014 | By Boehringer Ingelheim
Boehringer Ingelheim today announced the U.S. Food and Drug Administration (FDA) approved two different products at the end of last week.
29 July 2014 | By Johnson & Johnson
The U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.1 The FDA also approved IMBRUVICA for CLL patients with del 17p,1 a genetic…
25 July 2014 | By GlaxoSmithKline
GlaxoSmithKline plc announced that the U.S. Food and Drug Administration has approved Flonase® Allergy Relief (fluticasone propionate 50 mcg spray)...
24 July 2014 | By Novartis
Sandoz announced that the US Food and Drug Administration has accepted its Biologics License Application for filgrastim...
17 July 2014 | By Boehringer Ingelheim
Boehringer Ingelheim announced that for the first time the U.S. Food & Drug Administration has granted Breakthrough Therapy designation for a treatment in idiopathic pulmonary fibrosis...
