FDA Hits Valeant's Plaque Psoriasis Drug with a Complete Response Letter

FDA Hits Valeant's Plaque Psoriasis Drug with a Complete Response Letter

Ortho Dermatologics, a division of Quebec-based Valeant Pharmaceuticals International, received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Duobrii for plaque psoriasis. Duobrii is a combination of halobetasol propionate and tazarotene, which when used separately to treat plaque psoriasis, can only be used for […]

BRIEF-FDA Allows Label For Novartis' Drug Cosentyx To Include Psoriatic Arthritis Benefit

BRIEF-FDA Allows Label For Novartis' Drug Cosentyx To Include Psoriatic Arthritis Benefit

June 19 (Reuters) – Novartis AG: * NOVARTIS RECEIVES FDA APPROVAL FOR INCLUSION OF NEW EVIDENCE THAT COSENTYX® INHIBITS PROGRESSION OF JOINT STRUCTURAL DAMAGE IN PSORIATIC ARTHRITIS * NOVARTIS – RECEIVES FDA APPROVAL FOR INCLUSION OF NEW EVIDENCE THAT COSENTYX INHIBITS PROGRESSION OF JOINT STRUCTURAL DAMAGE IN PSORIATIC ARTHRITIS * NOVARTIS-NEW PRESCRIBING INFORMATION TO INCLUDE […]

Solid (SLDB) Surges as FDA Lifts Clinical Hold on DMD Drug

Solid (SLDB) Surges as FDA Lifts Clinical Hold on DMD Drug

Shares of Solid Biosciences Inc. (SLDB – Free Report) surged 10.9% after the company announced that the FDA has lifted the clinical hold on its phase I/II trial, IGNITE DMD, for its experimental candidate, SGT-001. SGT-001, Solid Biosciences’ lead candidate, is a microdystrophin gene transfer, which is being evaluated for the treatment of Duchenne muscular […]

Amphastar Pharmaceuticals receives FDA approval for its injectable heart drug

Amphastar Pharmaceuticals receives FDA approval for its injectable heart drug

() announced Tuesday that it has received approval from the US Food and Drug Administration for its heart drug, Isoproterenol Hydrochloride. The injectable drug used to treat mild blockage in the heart that doesn’t require electric shock or pacemaker therapy. The vials are available in various doses ranging from 0.2mg/mL to 5mL. READ: Shares […]

Glenmark Pharmaceuticals gets FDA approval to market NC-made drug

Glenmark Pharmaceuticals gets FDA approval to market NC-made drug

Glenmark Pharmaceuticals, an India-based global pharmaceutical company, has received its first U.S. Food and Drug Administration go-ahead to market one of its North Carolina-made drugs in the United States. The FDA’s supplemental Abbreviated New Drug Application (sANDA) approval puts a major “Open for Business” sign above the door at Glenmark’s pharmaceutical manufacturing facility in the […]

FDA could approve prescription drug made from marijuana plant

FDA could approve prescription drug made from marijuana plant

COLORADO SPRINGS, Colo. (KKTV) – The U.S. could soon have its first marijuana-derived medicine. But some people are worried about how it could impact states like Colorado, where medical marijuana already exists. Living in Colorado, if you have a medical marijuana card you can just stop by one of the many medical marijuana dispensaries and […]

New compound as potent as FDA drugs used to treat infections

New compound as potent as FDA drugs used to treat infections

© Shutterstock Purdue University researchers maintain a newly identified compound has proven to be as potent as FDA approved infection-fighting drugs and is less susceptible to bacterial resistance. Investigators said preliminary testing, outlined via the European Journal of Medicinal Chemistry, determined F6 has been potent against antibiotic-resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) and […]

Compound as Effective as FDA-Approved Drugs Against Life-Threatening Infections

Compound as Effective as FDA-Approved Drugs Against Life-Threatening Infections

Purdue University researchers have identified a new compound that in preliminary testing has shown itself to be as effective as antibiotics approved by the Food and Drug Administration to treat life-threatening infections while also appearing to be less susceptible to bacterial resistance. The compound, called F6, has been potent against antibiotic-resistant pathogens such as methicillin-resistant […]

Vitamin shop co-owner sold misbranded or foreign drugs not approved by FDA

Vitamin shop co-owner sold misbranded or foreign drugs not approved by FDA

CORPUS CHRISTI – A Corpus Christi woman admits to U.S. court that she knowingly possessed and sold diet drugs containing sibutramine. In 1997, the Food and Drug Administration (FDA) approved a prescription drug containing sibutramine under the trade name “Meridia” for the management of obesity. In October 2010, the FDA requested Meridia’s marketer to withdraw […]