FDA nod to AstraZeneca’s all-oral, fixed-duration therapy for CLL & SLL

The decision follows compelling data from the AMPLIFY Phase III trial, demonstrating that 77% of patients receiving the Calquence-venetoclax combination were progression-free at three years

FDA greenlights first all-oral, fixed-duration combo therapy for untreated CLL patients

The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy

Zydus receives final approval from USFDA for Bosentan tablets for oral suspension, 32 mg

Bosentan 32 mg tablets for oral suspension are indicated for the treatment of Pulmonary Arterial Hypertension

Novo Nordisk weathers pricing pressure, bets big on oral Wegovy

Operating profit fell 1% in Danish kroner to DKK 127.7 billion but rose 6% at constant exchange rates

India’s silent oral cancer crisis: Early detection could save thousands

Indoco Remedies bags USFDA nod for Lacosamide oral solution

The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa

Alumis reports breakthrough Phase 3 results for oral psoriasis therapy

The therapy was well tolerated through Week 24, with a safety profile consistent with Alumis’ Phase 2 data

Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug

The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety

RedHill Biopharma advances RHB-102 as once-daily oral therapy to combat GLP-1 side effects

The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation

Wegovy pill marks first GLP-1 weight-loss medicine in oral form

The approval introduces a needle-free alternative to injectable GLP-1 therapies