Pharma News - Drug/Product Approvals News & Articles

421 Abbott receives positive opinion for humira in non-radiographic axial spondyloarthritis from emas chmp Abbott, June 26, 2012

422 CHMP recommends novartis drug afinitor for EU approval marking major milestone in the treatment of advanced breast cancer Full Text Novartis, June 25, 2012

423 Osiris therapeutics announces the world's first approval of a stem cell therapy Full Text Pharmaceutical Technology, June 25, 2012

424 Novartis receives positive CHMP opinion for once-daily Seebri Breezhaler to treat COPD patients in the EU Full Text Novartis, June 25, 2012

425 Genotoxic impurities: a q&a with amgen's bo shen Full Text Pharmaceutical Technology, June 25, 2012

426 FDA encourages whistleblowers, just not its own Full Text Pharmaceutical Technology, June 25, 2012

427 Medtronic stent graft chosen by U.S. FDA for innovative program Full Text Medtronic, June 22, 2012

428 Physical-chemical identifiers: a q&a with FDA on the final guidance Full Text Pharmaceutical Technology, June 22, 2012

429 Lucinactant approved for premie RDS Full Text Drug Topics, June 21, 2012

430 Watson confirms favorable appeals court decision in sanctura XR patent suit Full Text Actavis, June 19, 2012

431 Genzyme submits applications to FDA and EMA for approval of lemtrada (alemtuzumab) for multiple sclerosis Full Text Genzyme, June 15, 2012

432 Genzyme submits applications to FDA and EMA for approval of lemtrada (alemtuzumab) for multiple sclerosis Full Text Sanofi, June 13, 2012

433 FDA approves Perjeta (pertuzumab) for people with HER2-positive metastatic breast cancer Full Text Roche, June 12, 2012

434 Sanofi submits application for regulatory approval for lyxumia (lixisenatide) for the treatment of type 2 diabetes in japan Full Text Sanofi, June 12, 2012

435 Novartis drug Gilenya shows long-term efficacy and safety according to new data from extension of phase III head-to-head study Full Text Novartis, June 12, 2012

436 FDA approves perjeta (pertuzumab) for people with her2-positive metastatic breast cancer Full Text Genentech, June 11, 2012

437 Medtronic files PMA application for FDA approval of minimed 530g system featuring threshold suspend automation Full Text Medtronic, June 11, 2012

438 Perjeta approved for her2-positive metastatic breast cancer Full Text Genentech, June 11, 2012

439 Gsk and xenoport receive FDA approval for horizant for postherpetic neuralgia XenoPort, June 8, 2012

440 Pathological complete response and accelerated drug approval in early breast cancer New England Journal of Medicine, June 8, 2012

1 U.S. FDA Approves INVOKANA (Canagliflozin) to Treat Adults with Type 2 Diabetes Janssen, April 1, 2013    Free full text

2 Daratumumab Granted Fast Track Designation from US Food and Drug Administration Genmab, April 3, 2013    Free full text

3 FDA approves treatment for postmenopausal women experiencing pain during intercourse Drug Topics, March 7, 2013    Free full text

4 FDA Releases Guidance on Non-Penicillin Beta-Lactam Drugs BioPharm International, April 18, 2013    Free full text

5 Merck Announces FDA Acceptance of New Drug Application for an Investigational Tablet Formulation of the Antifungal NOXAFIL (posaconazole) Merck, April 11, 2013    Free full text

6 CryoLife Receives FDA Clearance For Next Generation HeRO Device CryoLife, April 5, 2013    Free full text

7 Warner Chilcott Announces FDA Approval of New Oral Contraceptive Warner Chilcott, April 25, 2013    Free full text

8 Ospemifene: New treatment for postmenopausal women American Pharmacists Association News, April 5, 2013    Free full text

9 Bayer's Stivarga (regorafenib) Tablets Approved in Japan Onyx Pharmaceuticals, March 26, 2013    Free full text

10 Takeda and Millennium Announce Approval of ADCETRIS (Brentuximab Vedotin) in Switzerland Millennium Pharmaceuticals, April 8, 2013    Free full text

11 FDA approves Diclegis for pregnant women experiencing nausea and vomiting FDA Press Announcements, April 12, 2013    Free full text

12 FDA approves new multiple sclerosis treatment: Tecfidera FDA Press Announcements, April 1, 2013    Free full text

13 FDA approves once-monthly aripiprazole for schizophrenia Drug Topics, March 14, 2013    Free full text

14 Taro Receives FDA Approval For Topicort (desoximetasone) Topical Spray, 0.25% Taro Pharmaceuticals USA, April 15, 2013    Free full text

15 FDA Advisory Committee recommends approval of BREO ELLIPT for the treatment of COPD GlaxoSmithKline, April 19, 2013    Free full text

16 Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C Gilead, April 9, 2013    Free full text

17 FDA approves first Botulism Antitoxin for use in neutralizing all seven known botulinum nerve toxin serotypes FDA Press Announcements, March 25, 2013    Free full text

18 FDA Approves New Drug Application (NDA) for Tevas Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets for the Prevention of Pregnancy Teva Pharmaceutical Industries, April 10, 2013    Free full text

19 FDA approves Invokana to treat type 2 diabetes FDA Press Announcements, April 1, 2013    Free full text

20 Sarepta Therapeutics Announces FDA Will Consider Accelerated Approval for Eteplirsen After Further Review of Data on Dystrophin and Clinical Outcomes Sarepta Therapeutics, April 19, 2013    Free full text