FDA+ channel feed – Endpoints News

FDA+ channel feed

Tech glitches overshadow FDA oncology adcomm as a solid majority of advisers vote to keep Roche's Tecentriq in mTNBC

5 years ago

After facing a 16-month sojourn during Covid to overcome a stunning CRL, little Enzyvant says it's back on track — expects marketing decision later this year

5 years ago

For tailored, single-person antisense oligonucleotides, FDA offers guidance on nonclinical testing

5 years ago

Biden signs two bills to clarify new chemical entities, educate on biosimilars

5 years ago

UniQure gets another shot with hemophilia gene therapy after FDA lifts clinical hold; Neoleukin's IL-2 hopeful also cleared

5 years ago

FDA gives Axsome speedy review for depression drug, while other indications wait in the wings

5 years ago

J&J vaccinations resume as FDA, CDC confident in benefit-risk profile

5 years ago

ADC Therapeutics nabs its first approval as FDA offers a quick OK for its DLBCL cancer treatment

5 years ago

Roche, Bristol Myers, and Merck prep defense for 6 ‘dangling’ PD-(L)1 accelerated approvals, even though they failed confirmatory trials

5 years ago

Shorla Pharma scores an expedited review for its mystery candidate to treat T-cell malignancies

5 years ago

How the SCOTUS decision to gut the FTC could help biopharma companies

5 years ago

GlaxoSmithKline hustles the 7th PD-1 past the finish line with Jemperli. But how big will uptake be?

5 years ago

Senators to NIH: Do more to protect US biomedical research from foreign influence

5 years ago

Damn the critics, Biogen CEO Vounatsos orders full speed ahead on prepping a controversial aducanumab launch as FDA decision looms

5 years ago

Law professors call for FDA to disclose all safety and efficacy data for drugs

5 years ago

Why remote drug manufacturing evaluations won't really reduce FDA's backlog of inspections

5 years ago

FDA offers scathing review of Emergent plant's sanitary conditions, employee training after halting production

5 years ago

House Democrats call on Emergent execs to testify on quality issues next month

5 years ago

Opinion: US and EU reviews of blood clots and J&J’s Covid vaccine show why a transparent process matters

5 years ago

J&J to restart Covid vaccine shipments to Europe as EMA adds safety warning over rare blood clots

5 years ago

Amgen's promising gastric cancer drug makes good on Five Prime potential with FDA's breakthrough nod

5 years ago

FDA slaps a hold on KalVista's PhII study of an HAE drug, raising a red flag on preclinical results

5 years ago

FDA slaps a hold on Moffitt’s next-gen CAR-T as regulators demand another delay on clinical work — shares crater

5 years ago

When is a drug really a device? Court knocks down FDA appeal in trying to sort that grey area

5 years ago

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