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FDA approves vaccine for use after known or suspected anthrax exposure

IndicationFDA2015-11-24 10:52 Read   349

The U.S. Food and Drug Administration today approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease.

FDA approves Opdivo to treat advanced form of kidney cancer

BLA ApprovalFDA2015-11-24 09:42 Read   252

The U.S. FDA today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy.

FDA approves Ninlaro, new oral medication to treat multiple myeloma

BLA ApprovalFDA2015-11-21 21:07 Read   395

Today the U.S. Food and Drug Administration granted approval for Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy.

Vertex Receives EU Approval for ORKAMBI® (lumacaftor/ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Two Copies of the F508del Mutation

MarketVertex2015-11-20 17:12 Read   472

ertex Pharmaceuticals Incorporated today announced that the European Commission has granted Marketing Authorization for ORKAMBI® (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation.

FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose

DosageFDA2015-11-19 10:27 Read   287

Today the U.S. Food and Drug Administration approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose.

European Medicines Agency approves Xiapex® for concurrent treatment of palpable cords

BLA ApprovalSobi2015-11-18 11:09 Read   334

Sobi today announced that the EMA has approved Xiapex (collagenase clostridium histolyticum, or CCH) for the treatment of two Dupuytren's contracture (DC) cords concurrently.

FDA approves Darzalex for patients with previously treated multiple myeloma

BLA ApprovalFDA2015-11-17 10:41 Read   367

FDA granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma.

FDA approves new pill to treat certain patients with non-small cell lung cancer

NCE ApprovalFDA2015-11-16 15:27 Read   421

the U.S. Food and Drug Administration granted accelerated approval for an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC). Tagrisso (osimertinib) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy.

FDA approves modified antihemophilic factor for hemophilia A

BLA ApprovalFDA2015-11-16 12:26 Read   628

The U.S. Food and Drug Administration today approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A.

UPDATED: AstraZeneca wins big with fast FDA OK of AZD9291 for lung cancer

NCE ApprovalAstraZeneca2015-11-14 07:46 Read   604

AstraZeneca ($AZN) gained a crucial accelerated FDA approval for its targeted lung cancer drug AZD9291 today, offering tangible evidence of the R&D turnaround CEO Pascal Soriot had promised investors several years ago. And now the drug, to be marketed as Tagrisso, will be put to the market test to see if it can live up to Soriot's $3 billion peak sales estimate while staring down a strong rival in late-stage development at Clovis Oncology ($CLVS).

U.S. FDA Approves New Indications for Harvoni®, Gilead’s Once-Daily Single Tablet Regimen for Chronic Hepatitis C

IndicationGilead2015-11-13 11:17 Read   417

Harvoni – the first and only single-tablet regimen for the treatment of HCV – continues to demonstrate high cure rates and a tolerable side effect profile across a range of patient populations, including those who have historically been considered among the most difficult to cure

FDA Approves COTELLIC™ (Cobimetinib) for use in Combination with Vemurafenib to Treat Advanced Melanoma

CombinationExelixis2015-11-11 13:15 Read   494

Exelixis, Inc.today announced that FDA has approved COTELLIC™ (cobimetinib) as a treatment for patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib.