Pharma News - Drug/Product Approvals News & Articles

101 FDA Approves Longer Lengths of Medtronics Resolute Integrity Stent Full Text Medtronic, March 1, 2013

102 Bayer's Stivarga (regorafenib) Tablets Approved by U.S. FDA for Treatment of Patients with Locally Advanced, Unresectable or Metastatic GIST Full Text Onyx Pharmaceuticals, March 1, 2013

103 Medtronic Gains First FDA Approval to Conduct Early Feasibility Medical Device Study Full Text Medtronic, March 1, 2013

104 Sanofis Six-In-One Pediatric Vaccine Recommended for European Approval Full Text BioPharm International, February 28, 2013

105 Teva Announces FDA Approval of Generic Adderall XR Full Text Teva Pharmaceutical Industries, February 28, 2013

106 Structural Characterization of Monoclonal Antibodies Full Text BioPharm International, February 28, 2013

107 Sunovion Announces FDA Acceptance for Review of New Drug Application Resubmission for STEDESA (eslicarbazepine acetate) as a Once-Daily Adjunctive Therapy for Partial-onset Seizures in Adults with Epilepsy Full Text Sunovion, February 28, 2013

108 FDA approves new silicone breast implant Full Text FDA Press Announcements, February 27, 2013

109 FDA approves new treatment for late-stage breast cancer Full Text FDA Press Announcements, February 27, 2013

110 FDA approves Osphena for postmenopausal women experiencing pain during sex Full Text FDA Press Announcements, February 27, 2013

111 FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran) Full Text FDA What's New: Drugs, February 27, 2013

112 FDA approves Stivarga for advanced gastrointestinal stromal tumors Full Text FDA Press Announcements, February 27, 2013

113 FDA seeks input on minimizing disruptions to medical device supply chain during extreme weather events Full Text FDA Press Announcements, February 27, 2013

114 FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies Full Text FDA What's New: Drugs, February 27, 2013

115 Actavis Generic Suboxone Receives FDA Approval Full Text Actavis, February 27, 2013

116 FDA Warning: Driving May Be Impaired the Morning Following Sleeping Pill Use JAMA, February 25, 2013

117 FDA Drug Safety Communication: Planned return of CardioGen-82 to market with new Boxed Warning Full Text FDA What's New: Drugs, February 21, 2013

118 FDA Drug Safety Communication: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses Full Text FDA What's New: Drugs, February 21, 2013

119 FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone Full Text FDA What's New: Drugs, February 21, 2013

120 FDA Drug Safety Communication: Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs Full Text FDA What's New: Drugs, February 21, 2013

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