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FDA Advises to Avoid Cipro and Similar Drugs for Common Infections Due to Disabling Side Effects

The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolone should be reserved for those who do …

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AstraZeneca’s Thyroid Cancer Drug Granted Orphan Drug Status from the FDA

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational MEK 1/2 inhibitor, selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC). DTC is diagnosed in approximately 60,000 people in the US each …

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Allena’s Investigational Pediatric Hyperoxaluria Drug Receives Orphan Drug Designation from the FDA

NEWTON, Mass.–(BUSINESS WIRE)–Allena Pharmaceuticals, Inc., a specialty biopharmaceutical company focused on developing and commercializing innovative, non-systemic, oral protein therapeutics to treat metabolic and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Allena’s investigational therapy oxalate decarboxylase for the treatment of …

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Amgen’s sBLA for Blincyto Granted FDA Priority Review for Certain ALL Patients

THOUSAND OAKS, Calif., May 3, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia chromosome‑negative (Ph-) …

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FDA Approves Oral Suspension Formulation of Eisai’s Fycompa

WOODCLIFF LAKE, N.J., May 2, 2016 /PRNewswire/ — Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved FYCOMPA® (perampanel) CIII Oral Suspension as adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures in …

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FDA Approves Acadia’s Nuplazid for Parkinson’s-Related Psychosis

The U.S. Food and Drug Administration today approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease. Hallucinations or delusions can occur in as many as 50 percent of patients with Parkinson’s disease at some time during …

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FDA Authorizes Quest’s Zika Test for Emergency Use

MADISON, N.J., April 28, 2016 /PRNewswire/ — Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, today announced that it has received a U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test). The test …

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FDA Approves Collegium’s Abuse-Deterrent Opioid Painkiller Xtampza ER

CANTON, Mass., April 26, 2016 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced that the U.S. Food and Drug Administration (FDA) approved Xtampza™ ER (oxycodone) extended-release (ER) capsules CII, a twice-daily, oxycodone medication for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for …

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Exelixis’ Renal Cell Carcinoma Drug Receives FDA Approval

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) has approved CABOMETYX™ (cabozantinib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults. …

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FDA Panel Votes Against Sarepta’s Drug to Treat Duchenne Muscular Dystrophy

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Apr. 25, 2016– Sarepta Therapeutics, Inc.(NASDAQ:SRPT), a developer of innovative RNA-based therapeutics, today announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Advisory Committee (PCNSC) met to review the new drug application (NDA) for eteplirsen as a treatment for Duchenne muscular dystrophy amenable to exon 51 …

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