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Novartis (NVS) announced its supplemental Biologics License Application for Kymriah (tisagenlecleucel) suspension for intravenous infusion, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for or relapse after autologous stem cell transplant...

Teva Pharmaceutical Industries Ltd. (TEVA) said that the U.S. Food and Drug Administration has approved the use of TRISENOX or arsenic trioxide injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized...

AstraZeneca Plc (AZN.L, AZN) and Merck & Co., Inc., said that the US Food and Drug Administration has approved Lynparza (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast...

Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (VRX, VRX.TO), announced Friday that the U.S. Food and Drug Administration has accepted the New Drug Application for IDP-121 (tretinoin 0.05%) lotion (ALTRENO1) with a PDUFA action date of Aug. 27, 2018 for acne treatment. If...

TLANDO-Lipocine-meeting-011118.jpg Lipocine Inc.'s (LPCN) New Drug Application for TLANDO has failed to win support from an advisory committee to FDA, with only six members voting in favor and thirteen against the benefit/risk profile of the oral testosterone product candidate. Shares were down 53.47% to $1.61 in extended trading.

AstraZeneca (AZN.L, AZN) and its global biologics research and development arm, MedImmune, announced that the European Commission has approved Fasenra (benralizumab) as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled...

Merck & Co. Inc. (MRK) said that the U.S. Food and Drug Administration has accepted for review two New Drug Applications or NDAs for doravirine, the company's investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection in adults. The NDAs include data...

FDA-Approve-Dec2017-010518.jpg The process of drug development is challenging. Some drugs pass the FDA muster easily, while some face a host of hurdles before getting the official stamp of approval. Here's the list of new drugs, including novel drugs and biosimilars, which were approved in December 2017.

Amgen (AMGN) said that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application or sBLA for XGEVA or denosumab to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include...

Novartis (NVS) announced Thursday that the US Food and Drug Administration has granted Breakthrough Therapy designation to Promacta (eltrombopag) for use in combination with standard immunosuppressive therapy for the treatment of patients with severe aplastic anemia or SAA as a first-line therapy. The...

Palatin Technologies, Inc. (PTN) announced the U.S. FDA has notified the company that it may proceed with its clinical investigation of subcutaneous injection PL-8177 as a potential treatment for patients with ulcerative colitis. The notice to proceed was received following Palatin's submission of an...

Biosimilar Trastuzumab, co-developed by Biocon Ltd. and Mylan N.V. (MYL), has been approved by ANVISA, the Brazilian regulatory agency, through their partner Libbs Farmaceutica (Libbs), a leading Brazilian pharmaceutical company. Co-developed by Biocon and Mylan, this is the first biosimilar Trastuzumab...

The U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. The FDA permitted marketing of the Dermapace System to Sanuwave, Inc. The Dermapace System is intended to be used in the treatment of chronic,...

Agile Therapeutics, Inc. (AGRX) said that the U.S. Food and Drug Administration issued a complete response letter or CRL in response to the New Drug Application resubmission for the Company's investigational non-daily, low dose combination hormonal contraceptive patch, Twirla or AG200-15. The CRL stated...

Merck & Co. Inc. (MRK) and Pfizer Inc. (PFE) said that the U.S. Food and Drug Administration has approved Steglatro (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 or SGLT2 inhibitor, and the fixed-dose combination Steglujan (ertugliflozin and sitagliptin) tablets. Steglatro is indicated...

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