Tag: FDA

Immunomedics Announced FDA Acceptance of BLA for Sacituzumab Govitecan Approval

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Immunomedics, Inc., a leading biopharmaceutical company in the area of antibody-drug conjugates, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biolog...

FDA Approved 48 New Medicines in 2019

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After a flurry of activity in December, when the FDA approved seven new molecular entities (NMEs), the total of novel drugs that were given the green light this year reached 48, a number that ranks th...

Urovant Seeks FDA Approval for Vibegron

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Urovant Sciences announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of once-daily 75mg vibegron for the treatment of patients ...

MorphoSys AG Submitted BLA to FDA for Tafasitamab

MorphoSys AG, announced that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for tafasitamab, an anti-CD19 antibody, for the treatment of relapsed o...

FDA Granted Breakthrough Therapy Designation for Molgradex

Savara Inc., an orphan lung disease company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Molgradex, an inhaled formulation of recombinan...

Efforts to Improve Quality of Compounded Drugs from Outsourcing Facilities Taken by FDA

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Compounded drugs can serve an important role in meeting patients’ medical needs that cannot be met by an FDA-approved drug. Outsourcing facilities, a significant part of the industry producing compoun...

FDA Issued Complete Response Letter on Brinavess Approval

Correvio Pharma announced that the FDA issued a complete response letter regarding its filing seeking approval of Brinavess (vernakalant) for the rapid conversion of recent-onset atrial fibrillation i...

FDA Sent Response Letter to ViiV Healthcare on Cabotegravir and Rilpivirine Use

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Adm...

FDA Issued Two New Warnings to Drugmakers

The US Food and Drug Administration (FDA) recently warned Massachusetts-based device maker Conformis Inc. and Australian over-the-counter (OTC) drugmaker Wild Child WA Pty Ltd. for good manufacturing ...

Epizyme Submitted NDA to FDA for Accelerated Approval of Tazemetostat

Epizyme, Inc., a late-stage biopharmaceutical company developing novel epigenetic therapies, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)...

FDA Granted Priority Review to Pfizer sNDA for BRAFTOVI®

Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the Company’s supplemental New Drug Application (sNDA) for BRAFTOVI® (encorafenib) in...

FDA Recommended KEYTRUDA for Treatment of Certain Patients with NMIBC

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Merck, known as MSD outside the United States and Canada, announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) voted 9-4 in favor of recommending...

FDA Made Statement on Low-Cost Biosimilars

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Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is key for expanding access to these products and increasing competition, ultima...

FDA Recommended Lynparza for Metastatic Adenocarcinoma of Pancreas Treatment

AstraZeneca and MSD Inc., Kenilworth, NJ, US (MSD: known as Merck & Co., Inc. inside the US and Canada) announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee ...

Deciphera Pharmaceuticals Applied to FDA for Ripretinib Approval

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Deciphera Pharmaceuticals, Inc. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ripretinib, the Company’s investigational broad-spectrum KIT...

FDA Panel Voted in Favor of Horizon Experimental Treatment for Active Thyroid Eye Disease

Independent advisers to the U.S. Food and Drug Administration voted unanimously in favor of Horizon Therapeutics Plc’s experimental treatment for active thyroid eye disease, taking the drug closer tow...