Topic:

Regulatory

Latest Headlines

Latest Headlines

Tonix receives IND approval for sublingual formulation to treat PTSD

Tonix Pharmaceuticals announced June 10 that its investigational reformulation of cyclobenzaprine, TNX-102 SL, received IND clearance from the FDA for the treatment of post-traumatic stress disorder. The news comes about a month after the company said that TNX-102 SL's pivotal trial for the treatment of fibromyalgia completed enrollment.

FDA to vote on opioid-induced constipation pills

The FDA has announced it will vote this week on whether a class of drugs that treat opioid-induced constipation needs more clinical testing in light of a side effect: heart attack. The class of drugs includes recently approved products from Salix Pharmaceuticals and Cubist Pharmaceuticals but also one that AstraZeneca is developing with Nektar Theraputics.

China's FDA grants approval to Dehaier's portable sleep Dx system

China's Dehaier Medical Systems won regulatory approval in its home country for software crucial to its sleep diagnostic system, nearly a year after the process began.

Roche's Avastin and MabThera are added to list of those stolen in Italy

Authorities in Europe have added two Roche cancer drugs to their list of stolen meds that wholesalers and healthcare providers should be on the lookout for. That brings the tally to 5 drugs that the European Medicines Agency says should be closely examined for signs of tampering.

Dr. Reddy's avoids pitfalls of Ranbaxy, Wockhardt by cutting workers out of production

To avoid the fate of some of its competitors that have run afoul of the FDA over loose manufacturing standards, Dr. Reddy's and some other Indian drugmakers have decided it is worth investing hundreds of millions of dollars for new plants and equipment in a country that has traditionally relied on cheap human labor.

FDA green-lights addiction drug amid opioid controversy

The FDA has said repeatedly that it's committed to fighting the opioid epidemic, and to that end, it approved BioDelivery Sciences' Bunavail Friday to treat dependence on the drugs.

FDA clears new model of sleep apnea diagnostic device

The FDA approved the latest version of WatchPat, a home sleep diagnostic device.

UPDATED: Maine senator calls for price transparency of implants

Sen. Angus King of Maine proposed banning the common industry practice of preventing hospitals from revealing the price of their implants in a critical speech on the Senate floor.   

Kamra gets FDA panel OK, but safety concerns nag

In a close vote by FDA's Ophthalmic Devices Panel on Friday, the committee recommended the approval of the Kamra inlay intra-corneal implant from AcuFocus. But the panel also voted against the device being safe in the proposed indication.

Biogen Idec racks up another blockbuster FDA approval, this time for hemophilia

Just a couple of months after scoring a groundbreaking approval for its new hemophilia B drug, Biogen Idec has scored another FDA OK for Eloctate, a hemophilia A drug targeting a much broader blockbuster market.