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LEO Pharma Receives Scientific Approval of Enstilar® for the Treatment of Psoriasis in EU

CombinationLEO Pharma2016-03-22 10:43 Read   704

The marketing approval of Enstilar® would make it the first fixed combination topical foam treatment for people living with psoriasis vulgaris in the EU.

FDA approves new treatment for inhalation anthrax

BLA ApprovalFDA2016-03-22 09:53 Read   111

the U.S. FDA approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

Merz Announces European Approval of Bocouture for the Treatment of Upper Facial Lines

BLA ApprovalMerz Pharma 2016-03-18 12:40 Read   450

Merz Pharma Group today announced that Bocouture® has been approved by European regulatory authorities for the treatment of upper facial lines, including horizontal frown lines, lateral periorbital lines and glabellar frown lines.

FDA Approves Bayer's KOVALTRY® Antihemophilic Factor (Recombinant) for the Treatment of Children and Adults with Hemophilia A

BLA ApprovalBayer2016-03-18 10:18 Read   305

The U.S. Food and Drug Administration has approved Bayer's KOVALTRY® Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults.

FDA Grants Spectrum Pharmaceuticals Approval of EVOMELA™ (melphalan) for Injection

DosageSpectrum Pharmaceuticals2016-03-16 13:23 Read   185

Spectrum announced today that the U.S. FDA has granted approval of EVOMELA for use in two indications。

Teva Wins FDA Approval for First Viagra Generic, Will Not Launch Until 2017

GenericTeva2016-03-14 14:51 Read   179

Teva Pharmaceuticals will take a bite out of Pfizer’s blockbuster Viagra (sildenafil citrate) sales as the US Food and Drug Administration approved a generic version of the erectile dysfunction drug on Wednesday.

FDA expands use of Xalkori to treat rare form of advanced non-small cell lung cancer

IndicationFDA2016-03-14 09:34 Read   151

The U.S. FDA today approved Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration.

U.S. FDA Approves IMBRUVICA® (ibrutinib) for First-line Treatment of Chronic Lymphocytic Leukemia

IndicationJanssen2016-03-07 10:43 Read   184

The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) capsules for treatment-naïve patients with chronic lymphocytic leukemia (CLL).

FDA approves first coagulation factor-albumin fusion protein to treat patients with hemophilia B

BLA ApprovalFDA2016-03-07 09:26 Read   173

The U.S. FDA today approved Idelvion, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, for use in children and adults with Hemophilia B.

FDA Approves New Indication for FASLODEX® (fulvestrant)

IndicationAstraZeneca2016-03-04 11:05 Read   154

AstraZeneca today announced that the US FDA has approved a new indication expanding the use of FASLODEX® (fulvestrant) to include use in combination with palbociclib.

U.S. Food and Drug Administration Approves Gilead’s Second TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection

New CombinationGilead Sciences2016-03-03 14:33 Read   296

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Odefsey® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients.

Allergan Announces FDA Approval of ACZONE® (dapsone) Gel, 7.5% for Treatment of Acne Vulgaris

DosageAllergan2016-02-29 17:16 Read   179

Allergan plc , a leading global pharmaceutical company, today announced that the Company has received approval from the U.S. FDA to market ACZONE® (dapsone) Gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older.