Pharma News, 2022

The FDA’s decision not to approve Spero Therapeutics’ oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic resis...

The European Commission has approved two Sanofi enzyme replacement therapies, Xenpozyme (olipudase alfa) and Nexviadyme (avalglucosidase alfa).

Pfizer Inc (PFE.N) said on Thursday it is seeking full U.S. approval for its oral COVID-19 antiviral treatment Paxlovid, which is currently available under an emergency use authorization (EUA). ...

New calculations by the European Environmental Agency (EEA) have definitively proven the link between pollution and cancer.

Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disor...

Initial results from Jazz Pharmaceuticals' Phase III study of Sativex (JZP378) for the treatment of multiple sclerosis failed to achieve the primary endpoint of an improvement in muscle tone. ...

Gilead Sciences has refiled for FDA approval of its HIV capsid inhibitor lenacapavir – which only needs to be dosed every six months – after the drug was rejected by the regulator in February. ...

Ipsen is expanding its cancer drug portfolio with the purchase of Epizyme for $247 million, gaining access to the company’s chemotherapy-free EZH2 inhibitor, Tazverik (tazemetostat). ...

In interim results from a mid-stage study, GlaxoSmithKline’s hepatitis drug candidate bepirovirsen showed the potential to suppress both the surface antigen and the virus of hepatitis B after 24 ...

The EMA’s human medicines advisory committee has recommended that BioMarin Pharmaceutical’s haemophilia A gene therapy Roctavian be approved in the EU, removing one of the last barriers to laun...

Women in the United States are largely uninformed when it comes to some critical health issues, including their relatively higher risk of developing Alzheimer’s disease as compared to men, accord...

A federal judge is letting stand a $6.4 billion claim that Bristol Myers Squibb stalled its CAR T cell therapy Breyanzi (lisocabtagene maraleucel) from getting to the market in order to duck out of...