Pharmaceutical

Compliance standards in medicines are evolving rapidly....

The regulatory framework governing medicine development is in flux. CDMOs face g...

Erasca’s ERAS-801 gains FDA orphan drug designation for...

Erasca has obtained orphan drug designation (ODD) from the US FDA for ERAS-801 t...

Talaris Therapeutics to merge with Tourmaline Bio

Talaris Therapeutics has entered into a definitive agreement to merge with late-...

Kymera’s novel MDM2 degrader granted orphan designation...

Kymera Therapeutics has announced that the FDA has granted KT-253 orphan drug de...

AbbVie’s migraine medication Qulipta gets positive CHMP...

The medication could be a strong contender in the EU migraine market as a daily ...

Diabetes will be ‘a defining disease of this century’ a...

"The world has failed to understand the social nature of diabetes and underestim...

STAT+: FDA rejects Intercept’s NASH drug, prompting a p...

The FDA rejected Intercept’s investigational treatment for NASH on Thursday, der...

CMS proposes new pathway for reimbursing breakthrough d...

The new rule doesn't explicitly make getting reimbursement easier, but it will a...

STAT+: Congress explores changes to the way Medicare pa...

Lawmakers in both parties talked about overhauling a 2015 law, MACRA, that sets ...

The best AI opportunities, tech to improve 988, and an ...

In the latest edition of STAT's Health Tech newsletter: The best AI opportunitie...

Opinion: The FDA’s approval of a new gene therapy for D...

This is not the final victory for people with Duchenne muscular dystrophy. It is...

STAT+: Medicare puts out new details for covering the A...

The floodgates could open if the FDA approves Leqembi next month. Medicare just ...

Listen: Messy PBM conflicts, debatable vaccines, & the ...

Who's watching the drug price watchmen? Are RSV vaccines too expensive? And is i...

STAT+: FDA grants conditional approval to Sarepta’s gen...

The Food and Drug Administration granted conditional approval Thursday to the fi...

STAT+: The strategy behind the pharmaceutical industry’...

Legal experts unpacked the pharmaceutical industry's scattershot approach to cha...

FDA moves to stop vape shops from selling Elf Bar, Esco...

The FDA is ramping up its efforts to force vape shops and other retailers to sto...