The FDA has approved Genentech’s inavolisib (Itovebi) in combination with the CDK4/6 inhibitor palbociclib and the oestrogen-receptor antagonist fulvestrant for endocrine-resistant, PIK3CA ...

The U.S. FDA recently approved FluMist as a self or caregiver-administered nasal spray flu vaccine to prevent Influenza disease. The nasal spray prevents the flu from Influenza virus subtypes A ...

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 ...

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 ...

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 ...

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 ...

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 ...

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. The FDA on Friday gave Vyloy (zolbetuximab) the thumbs-up ...

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 ...

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 ...

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 ...

Baxter has received FDA approval to extend the shelf life of more than 50 intravenous and irrigation products by up to 12 months, now allowing for a 24-month expiry from products made before ...