Teva Pharmaceuticals USA snagged US Food and Drug Administration (FDA) final approval for the first generic naloxone hydrochloride nasal spray known as Narcan, the agency announced on Friday.

FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose Treatment and more...

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FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose Treatment

Teva Pharmaceuticals USA snagged US Food and Drug Administration (FDA) final approval for the first generic naloxone hydrochloride nasal spray known as Narcan, the agency announced on Friday.

      
 

Roche throws in the towel on Tecentriq bladder, myeloma trials

Roche’s Tecentriq has scored some important victories lately, including a pair of first-in-class approvals. But in other types of cancer, the Swiss drugmaker has decided to pull the plug.

In a Wednesday update to its pharma pipeline, Roche listed two phase 1 Tecentriq studies—one in non-muscle invasive bladder cancer and one in multiple myeloma—that it had cast aside.

      
 

Consumer watchdog petitions FDA for black box warning on Amgen's Prolia

The FDA has warned patients using Amgen’s osteoporosis drug Prolia that stopping treatment could lead to an increased risk of spinal fractures. Now, a consumer watchdog said the warnings haven’t gone far enough.

      
 

Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH

In comments to US Food and Drug Administration (FDA) February draft guidance, industry experts called on the agency for alignment of the approaches to voluntary consensus standards (VCS) recognition.

      
 

Pfizer, Lilly to mull anti-NGF mAb's future after joint safety events spike in long-term readout

With the latest Phase III data for Pfizer and Lilly's tanezumab showing a long-term increase in the incidence of a safety concern that has dogged the anti-NGF mAb, the partners said late Thursday they now plan to review the totality of data from the tanezumab program with regulatory authorities to determine next steps.

      
 

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