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MannKind receives FDA Complete Response letter for AFREZZA NDA
MannKind Corporation (Nasdaq:MNKD) today announced that it has received a Complete Response letter from the U.S.Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for AFREZZA (insulin human [rDNA origin]) Inhalation...
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FDA Requests Additional Information Regarding AFREZZA in Complete Response Letter to MannKind
- MannKind Corporation (Nasdaq:MNKD) today announced that it has received a Complete Response letter from the U.S.Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for AFREZZA (insulin human [rDNA origin]) Inhalation Powder...
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FDA Requests Additional Information Regarding AFREZZA in Complete Response Letter to MannKind
Regulatory Updates Breaking News News source: Business Wire MannKind Corporation (Nasdaq:MNKD) today announced that it has received a Complete Response letter from the U.S.Food & Drug Administration (FDA) regarding the New Drug Application (NDA)...
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MannKind's inhaled insulin drug Afrezza delayed
MannKind's much-watched inhaled insulin product Afrezza has received a complete response letter from the FDA.According to a release, the letter requests more information related to several areas of the NDA. The good news for MannKind is that the...
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Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly Submission
Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (...
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Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly Submission
Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (...
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Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly Submission
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the...
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Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly
PRNewswire-FirstCall/ --Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the...
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Amylin, Lilly and Alkermes Receive Complete Response Letter from FDA for exenatide Once Weekly Submission
Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (...
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Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly Submission
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the...
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Amylin, Lilly and Alkermes Receive Complete Response Letter from
Amylin Pharmaceuticals, Inc.AMLN, Eli Lilly and Company LLY and Alkermes, Inc. ALKS today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON ...
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Amylin, Lilly and Alkermes Receive Complete Response Letter from FDA for exenatide Once Weekly Submission
Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (...
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Amylin, Lilly and Alkermes Receive Complete Response Letter from FDA for exenatide Once Weekly Submission
BYDUREON (exenatide for extended-release injectable suspension) Proposed Name Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN), (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete...
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Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly Submission
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the...
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Dainippon Sumitomo Pharma America Announces FDA Acceptance of Lurasidone New Drug Application for Tr
Dainippon Sumitomo Pharma America, Inc.(DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), today announced that the U.S. Food and Drug Administration (FDA) recently accepted for review the lurasidone New Drug Application (NDA)...
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FDA Advisory Committee Recommends Approval of Intermune's Esbriet
The U.S.Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee voted nine-to-three to recommend approval of Esbriet (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis to reduce decline in lung function.
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Neoprobe Announces Successful Meeting on Lymphoseek Phase 3 Results
Let the jobs come to you!Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that it recently met with the United States Food and Drug Administration (FDA) to...
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Neoprobe Announces Successful Meeting on Lymphoseek Phase 3 Results
Clinical Trials Update Breaking News News source: Business Wire Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that it recently met with the United States Food...
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Neoprobe Announces Successful Meeting on Lymphoseek Phase 3 Results
DUBLIN, OHIO-- (BUSINESS WIRE) -- Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that it recently met with the United States Food and Drug Administration (FDA)...
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Neoprobe meets with FDA to review Phase 3 clinical trial results of Lymphoseek drug
Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that it recently met with the United States Food and Drug Administration (FDA) to review the clinical trial...
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ADVENTRX Receives Brand Name Acceptance for ANX-530
SAN DIEGO, March 12 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc.(NYSE Amex: ANX) today announced that the U.S. Food and Drug Administration (FDA) has accepted the proposed proprietary name "Exelbine" for the Company's product candidate ANX-530 ...
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FDA accepts proposed proprietary name Exelbine for ADVENTRX Pharmaceuticals' ANX-530
ADVENTRX Pharmaceuticals, Inc.(NYSE Amex: ANX) today announced that the U.S. Food and Drug Administration (FDA) has accepted the proposed proprietary name "Exelbine" for the Company's product candidate ANX-530 (vinorelbine injectable emulsion). "We are...
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Spherical Crystallization for Lean Solid-Dose Manufacturing (Part 1)
In Part I of this article, the authors describe the materials and methods used in developing a screening strategy to accelerate the preparation and characterization of spherical agglomerates by spherical crystallization.By: Tu Lee, Yan Chan Su, Hung Ju Hou,...
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ADVENTRX Pharma (ANX) ANX-530 Name 'Exelbine' Accepted by U.S. FDA
ADVENTRX Pharmaceuticals, Inc.(AMEX: ANX) today announced that the U.S. Food and Drug Administration (FDA) has accepted the proposed proprietary name "Exelbine" for the Company's product candidate ANX-530 (vinorelbine injectable emulsion). "We are...
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US FDA committee recommends approval of InterMune's Esbriet for idiopathic pulmonary fibrosis
InterMune, Inc announced that the US Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 9-3 to recommend approval of Esbriet (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to...
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