The FDA has approved a new oral antibiotic to treat uncomplicated urinary tract infections. Orylnvah is a broad-spectrum oral penem antibiotic for women who have limited or no alternative ...

The US Food and Drug Administration (FDA) approved a new oral antibiotic to treat uncomplicated urinary tract infections (uUTIs). Orlynvah (sulopenem etzadroxil and probenecid) is a broad-spectrum ...

WASHINGTON — Jazz Pharmaceuticals lost its bid to overturn the approval of another company’s rival sleep drug when a D.C. federal judge ruled that the FDA did not violate the Orphan Drug Act when ...

Six months after scoring FDA approval for hemophilia B gene therapy Beqvez, Pfizer has earned a nod from the U.S. regulator for another of its products in the indication. On Friday, the FDA signed ...

If the efficacy and safety data stands up to deeper scrutiny and support approval, Madrigal will have succeeded where so many other companies have failed in NASH, including Gilead Sciences, Genfit ...

Pfizer’s bivalent RSV prefusion F vaccine has been approved to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at ...

The Food and Drug Administration approved a drug produced by AbbVie for the treatment of late stage Parkinsons disease the company announced Thursday. The regulator approved Vyalev, also known as ...

The US Food and Drug Administration (FDA) has approved AbbVie's VYALEV (foscarbidopa and foslevodopa) to treat motor fluctuations in adults with advanced Parkinson's disease (PD). The chronic ...

Novocure received a long-sought FDA approval for the use of its Tumor Treating Fields technology against metastatic non-small cell lung cancer—which the company described as the first treatment ...

The UK's drugs regulator—the MHRA—has approved the Alzheimer's drug donanemab, but it won't be available on the NHS. The National Institute for Health and Care Excellence (Nice), which ...

(NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved HYMPAVZI™ (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding ...

Rahul Sidhu does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond ...