The FDA is offering a look into why it denied about 60% of all breakthrough therapy designation requests it received from the biopharma industry —
House Republicans on Thursday gave the FDA a final warning to produce documents relating to FDA-funded Covid-19 research, which the lawmakers are concerned could pose
The Alliance Defending Freedom, a conservative Christian advocacy group, on Thursday filed a brief asking the Supreme Court to deny Danco Laboratories’ and the Biden
The Senate Finance Committee on Wednesday advanced a package of bills that sets out to lower drug costs for Medicare and Medicaid beneficiaries, including reforms
Monica Bertagnolli passed through the final step to become President Biden’s first Senate-confirmed NIH director in nearly two years with a 62-36 vote on Tuesday.
FDA’s biologics leader Peter Marks has a warning for gene therapy manufacturers and the healthcare payers that cover them: If they can’t streamline manufacturing in
After the FDA unveiled its overarching IT strategy earlier this fall, lobbying groups like BIO and PhRMA, as well as tech giant Google, are asking
The FDA on Thursday approved Phathom Pharmaceuticals’ potassium-competitive acid blocker Voquezna (vonoprazan) to treat erosive gastroesophageal reflux disease (GERD), offering a new class of treatment
Republicans in the House Committee on Energy and Commerce are threatening to subpoena FDA Commissioner Rob Califf if the agency doesn’t produce information on its
Novartis on Tuesday nabbed another indication for its biologic Cosentyx (secukinumab), this time in the growing field of treatments targeting the skin condition hidradenitis suppurativa