The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

Sarepta and Roche face a regulatory setback as the EMA's CHMP issues a negative opinion on Elevidys for Duchenne muscular ...

Xuewu Liu, a Chinese inventor who has no medical training or credentials of any kind, is charging cancer patients $20,000 for ...

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...

The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...

The FDA has accepted the resubmitted BLA for tabelecleucel (tab-cel), intended for the treatment of Epstein-Barr virus ...

Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.

The FDA's 'Elsa' AI, intended to speed up drug approvals, is reportedly fabricating studies, part of a wider trend of ...

Nootropics are substances that enhance cognitive performance through various mechanisms, including cholinergic, glutamatergic, and dopaminergic pathways. They include prescription medications, natural ...

Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...

The Trump administration is inching closer to banning fluoride tablets and drops often prescribed to kids who don’t have ...

Replimune stock fell after the FDA rejected its RP1 application, citing flaws in the trial design and lack of substantial evidence for approval.