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Bio Products Laboratory Receives European Approval for Coagadex® (Human Coagulation Factor X)

BLA ApprovalBio Products Laboratory2016-04-02 12:37 Read   142

First-ever treatment for rare bleeding disorder ‘hereditary factor X deficiency’ approved in Europe

Bayer Receives Approval for Kovaltry® for the Treatment of Hemophilia A in Japan

BLA ApprovalBayer2016-03-31 11:02 Read   143

Bayer has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for Kovaltry®, a full-length unmodified, recombinant factor VIII product for the treatment of hemophilia A.

FDA approves Cinqair to treat severe asthma

BLA ApprovalFDA 2016-03-24 09:27 Read   143

The U.S. Food and Drug Administration today approved Cinqair (reslizumab) for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older. Cinqair is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.

FDA approves new psoriasis drug Taltz

BLA ApprovalFDA2016-03-23 09:00 Read   143

The U.S. Food and Drug Administration today approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. 

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 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.

EU green light for Lilly's lung cancer drug Portrazza

BLA ApprovalLilly2016-02-27 12:45 Read   163

European regulators have approved Eli Lilly’s Portrazza as a treatment for patients with advanced non-small cell lung cancer (NSCLC).

FibCLOT®, Human Fibrinogen from LFB, Obtains First Marketing Authorisations in Europe

BLA Approval LFB SA2016-02-24 14:13 Read   263

LFB SA announces it has obtained the first three European marketing authorisations for its human fibrinogen, in Germany, Denmark and Hungary, via a decentralised licensing procedure. Thirteen more marketing authorisations are expected in Europe in the coming months.

Bayer's new haemophilia A drug cleared in Europe

BLA ApprovalBayer2016-02-23 16:55 Read   157

European patients with the haemophilia A could soon get access to a new treatment option after regulators approved Bayer’s Kovaltry for all age groups.

Takeda Announces New Drug Application Approval in Japan for a Haemophilus influenzae type b conjugate vaccine, "VAXEM Hib®"

BLA ApprovalTakeda2016-01-29 08:34 Read   237

Takeda Pharmaceutical Company Limited  today announced that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application (“NDA”) for a conjugate vaccine to prevent infections caused by Haemophilus influenzae type b (Hib) in children aged from 2 months to under 5 years of age.