CMS announced a new policy late Tuesday that will allow Medicare Advantage plans to use a “step therapy” approach to control prescription drug costs for patients in an effort to…

An FDA advisory panel voted Wednesday in favor of the safety and efficacy of Paratek’s two NDAs for omadacycline tablets and omadacycline injection as treatments for community-acquired bacterial pneumonia (CAPB)…

The FDA Wednesday approved drug products under the Competitive Generic Therapy (CGT) designation for the first time, granting approval to several strengths of Apotex’s potassium chloride oral solution. Source: Drug…

An FDA advisory committee voted Tuesday in favor of the safety and effectiveness of Insmed’s NDA amikacin for treatment of nontubercuolous mycobacterial (NTM) lung disease for patients with limited treatment…

The FDA Tuesday finalized its recommendations on how drug sponsors submitting applications should control elemental impurities in their drug products. Source: Drug Industry Daily

The FDA warned Montreal, Quebec-based drugmaker Les Produits Chimiques that serious quality unit failures caused its APIs to be adulterated. Source: Drug Industry Daily

Insurance giant Humana sued more than two dozen generic drugmakers in a federal court on Aug. 3 alleging they conspired to inflate prices for commonly used drugs. Source: Drug Industry…

The FDA sent a warning letter to Connecticut-based drugmaker Milbar Laboratories for quality deficiencies and failure to investigate out-of-specification batches. Source: Drug Industry Daily

UK drug manufacturers will retain access to EU markets during the Brexit implementation period, the MHRA said in an update Monday, noting EU authorities will continue to recognize the UK’s…

The FDA unveiled new draft guidance Monday on nonclinical testing of orally-inhaled drug products that contain nicotine — and Commissioner Scott Gottlieb said the agency plans to release follow-up guidelines…