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Alexion Pharmaceuticals, Inc. (ALXN) submitted on Tuesday a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of ALXN1210, the Company's investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria...

valeant.jpg Shares of Valeant Pharmaceuticals International Inc. are falling more than 6 percent in Monday's trading following news that the U.S. Food and Drug Administration has failed to approve the Canada-based company's Duobrii lotion for the treatment of plaque psoriasis. Ortho Dermatologics, a division of Valeant Pharmaceuticals, said it has received a Complete Response Letter or CRL from the FDA.

Johnson & Johnson Vision, a unit of Johnson & Johnson (JNJ), said that the U.S. Food and Drug Administration (FDA) has approved of the iDESIGN Refractive Studio, making it the only system to use topography-integrated, wavefront-guided technology. This allows doctors to take a precise measurement of...

Bristol-Myers Squibb Company (BMY) announced that the China National Drug Administration has approved Opdivo or nivolumab injection for the treatment of locally advanced or metastatic non-small cell lung cancer or NSCLC after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic...

The U.S. Food and Drug Administration approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. Mylan Technologies Inc. and Dr. Reddy's Laboratories SA received approval to market buprenorphine and...

Amgen Inc. (AMGN) said that the U.S. Food and Drug Administration has approved the supplemental New Drug Application or sNDA to add the positive overall survival (OS) data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information for Kyprolis, or carfilzomib. According to Amgen, data added...

China Biologic Products Holdings, Inc. (CBPO) a plasma-based biopharmaceutical company in China, said that its majority-owned subsidiary, Shandong Taibang Biological Products Co. Ltd., recently obtained approval from the China Food and Drug Administration or CFDA to begin human clinical trials on its...

Amgen Inc. (AMGN) said Friday that the European Commission or EC has approved a new indication for Prolia, or denosumab, for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. The EC approval is based on the positive...

Eli Lilly and Company (LLY) announced the U.S. FDA has granted approval for a new indication for ALIMTA (pemetrexed for injection) in combination with carboplatin and KEYTRUDA (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer, irrespective of...

Genentech, a member of the Roche Group (RHHBY), announced Tuesday that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application or sBLA and granted Priority Review for HEMLIBRA (emicizumab-kxwh) for adults and children with hemophilia A without factor...

Sandoz, a Novartis division (NVS), said Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has adopted a positive opinion for marketing authorization of a proposed biosimilar adalimumab. The CHMP opinion recommends the proposed Sandoz biosimilar...

Pfizer Inc. (PFE) said that the United States Food and Drug Administration approved XELJANZ or tofacitinib 10 mg twice-daily or BID for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID, for the treatment of adult patients in the U.S. with moderately to severely active ulcerative colitis...

The FDA has finally approved TherapeuticsMD Inc.'s (TXMD) TX-004HR, branded as IMVEXXY, an applicator-free vaginal estradiol softgel.

Pfizer Inc. (PFE) said that the U.S. Food and Drug Administration or FDA granted Breakthrough Therapy designation for Xalkori, or crizotinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based...

TransEnterix, Inc. (TRXC) announced it has received FDA 510(k) clearance for expanded indications of its Senhance Surgical System. The company received FDA 510(k) clearance for laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery. "This indication expansion...

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