Philogen resubmits EMA marketing application for Nidlegy with updated Phase III melanoma data

According to the company, the PIVOTAL study demonstrated that Nidlegy reduced the risk of relapse or death compared with the control arm

FDA approves first over-the-counter Tylenol & Naproxen tab for 12-hour pain relief

The approval marks the first time naproxen sodium has been combined with acetaminophen in a single nonprescription tablet

EU panel backs AstraZeneca's Enhertu for metastatic breast cancer treatment

GSK wins FDA approval for Jideytro after Nuvalent acquisition

ROS1-targeted therapy becomes GSK's first marketed lung cancer drug, expanding its oncology portfolio

TSI receives Turkish regulatory authorization to initiate Phase 2 PROMPT-STEMI trial

The authorization permits the study to commence at the clinical centers included in the approved application

Eli Lilly's retatrutide delivers major weight loss results in two late-stage obesity trials

Lilly said it plans to submit a Biologics License Application (BLA) for retatrutide to the U.S. Food and Drug Administration in the first quarter of 2027

Glenmark secures FDA nod to expand RYALTRIS's use for younger children in US

The expanded indication is backed by results from a Phase 3 randomized, double-blind, placebo-controlled study

EU approves JASCAYD: first new IPF treatment for patients with progressive lung disease

Alembic Pharma's partner NATCO secures tentative FDA approval for generic Olaparib tablets

The company to commercialize the oncology drug in the U.S.; reference product Lynparza recorded a market size of nearly USD 1.4 billion

Oh Boey! Allergan Aesthetics wins European approval for fast-acting short-duration wrinkle treatment

Novo Nordisk wins EU approval for Wegovy pill in Europe

The approval is supported by results from Novo Nordisk’s OASIS clinical trial programme

FDA nod to Merck’s first once-daily oral PCSK9 inhibitor to cut LDL cholesterol

TolerogenixX wins EMA orphan drug designation for kidney transplant therapy MIC-Lx

TolerogenixX is developing MIC-Lx as a personalized cell therapy designed to induce donor-specific immune tolerance before living-donor kidney transplantation

CDSCO approves India-developed synthetic Cannabidiol Oral Solution for anxiety disorders

Leiutis Pharmaceuticals and Zenara Pharma secure world's first approval for fully synthetic CBD therapy for mild to moderate anxiety

FDA expands approval of PADCEV-Keytruda regimen for muscle-invasive bladder cancer

The study demonstrated a 47% reduction in the risk of tumor recurrence, progression or death,

AstraZeneca licenses respiratory drug from Sino Biopharma in potential $1.9 billion deal

The deal further strengthens company's respiratory pipeline as the company continues to expand its portfolio across chronic respiratory diseases.

Wegovy approved in UK to treat serious liver disease linked to obesity and diabetes

While semaglutide is already authorised for weight management in adults and adolescents, as well as reducing cardiovascular events in adults.

HUTCHMED wins China nod for ORPATHYS in rare & hard-to-treat gastric cancer

The drug is now approved for adults with locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma

WHO fast-tracks first diagnostic test for Ebola bundibugyo virus amid escalating outbreak crisis

The listing covers the first test capable of detecting Ebola Bundibugyo virus disease by identifying its genetic material in blood samples

Sobi receives FDA setback on NASP but no safety or efficacy concerns raised

Sobi said it will request a meeting with the FDA to review the feedback