BioCryst wins FDA approval for Orladeyo oral pellets

BioCryst Pharma (BCRX) announced on Friday that the U.S. Food and Drug Administration (FDA) approved an oral pellet ...

BioCryst Announces FDA Approval of ORLADEYO® (berotralstat) Oral Pellets, First and Only Oral Prophylactic Treatment for Patients with HAE Aged 2 to <12 Years

ORLADEYO now first and only targeted oral prophylactic therapy for patients with HAE aged 2 and older – -Oral pellet formulation provides ...
STAT

FDA approves first new gonorrhea drug in decades

The drug is from a new class of antibiotics, the first new class in decades to be approved as a treatment for gonorrhea, ...

US FDA expands use of GSK's Blujepa as treatment for gonorrhea

The U.S. Food and Drug Administration said on Thursday it has expanded the use of GSK's Blujepa as an oral treatment for ...

FDA moves to expand sunscreen options, proposing ingredient used in Asia and Europe

The FDA has proposed adding bemotrizinol, a new sunscreen ingredient, to the U.S. approval list, which could expand consumer ...
The American Journal of Managed Care

FDA Approves Sibeprenlimab for Immunoglobulin A Nephropathy

Sibeprenlimab is approved for IgAN treatment, showing a 51.2% reduction in proteinuria in the VISIONARY trial. Administered subcutaneously every four weeks, it inhibits APRIL to reduce IgA levels.
STAT

FDA approves Otsuka kidney disease therapy

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast ...
Nature

FDA approves 100th small-molecule kinase inhibitor

“It was a really hard sell,” recalls Druker, an oncologist and CEO of the Oregon Health & Science University Knight Cancer Institute, decades on. There were seemingly valid concerns at the time, he ...
FierceBiotech

FDA rejects Biohaven approval request for troriluzole, triggering R&D cost cutting

The FDA has rejected Biohaven’s request for approval of a neurological disorder therapy, prompting the biopharma to reprioritize its pipeline in order to shrink its annual R&D spend by 60%. After a ...
Nature

FDA approves PDE4 inhibitor for IPF

Boehringer Ingelheim has secured FDA approval for its PDE4 inhibitor nerandomilast (Jascayd) for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic and fatal lung disease. Nerandomilast ...
Cure Today

Covering Every FDA Oncology Approval From October 2025

Revuforj, a menin inhibitor, is approved for relapsed/refractory NPM1-mutant AML, offering new hope for patients with limited treatment options. Blenrep combined with Velcade and dexamethasone ...
The Hill

FDA to streamline approvals of generic biologic drugs

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...