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Human Drugs

FDA OKs Sanofis Fluzone Quadrivalent for Infants

FDA approves Sanofi Pasteurs 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) to include children age 6 through 35 months.

Human Drugs

FDA AIM2CERV Clinical Hold

FDA puts a partial clinical hold on Advaxis Phase 3 trial of AXAL for cervical cancer.

Human Drugs

Teligent Generic Temovate Ointment Approved

FDA approves a Teligent ANDA for a generic copy of Fougera Pharmaceuticals Temovate (clobetasol propionate ointment USP) 0.05%.

Medical Devices

AdvaMed Bill Addresses Some FDA Shutdown Issues

AdvaMed proposes legislation to allow FDA to continue to collect user fees and review medical device applications associated with those fees during an...

Human Drugs

SCOTUS Backs Teva in Aloxi Patent Dispute

The Supreme Court refuses to reinstate Hellsins Aloxi patent, supporting Tevas launch of a generic form of the anti-nausea drug last year.

Medical Devices

J&J, DePuy Settle with 46 States on Hip Devices

Attorneys general in 46 states reach a $120 million settlement with DePuy to resolve complaints that the company illegally promoted two metal-on-metal...

Medical Devices

Perspectum Diagnostics 510(k) for MRCP+ Cleared

FDA clears a Perspectum Diagnostics 510(k) for MRCP+ biliary visualization software.

Human Drugs

Torrent Pharma Expands Losartan Recall

Torrent Pharmaceuticals expands its recall from 10 lots of losartan potassium tablets to include six lots of losartan potassium and hydrochlorothiazid...

Medical Devices

Rebound Therapeutics Aurora Surgiscope Cleared

FDA clears a Rebound Therapeutics 510(k) for the Aurora Surgiscope System, a single-use disposable neurosurgical endoscope for minimally invasive acce...

Human Drugs

FDA Accepts 2 Merck sNDAs for HIV Drugs

FDA has accepted for review two Merck supplemental NDAs for HIV-treating drugs Pifeltro (doravirine, 100 mg) and Delstrigo (doravirine 100 mg, lamivud...