Approvals & Launches

If finally fully approved in its first indication, the HGF gene therapy could become a first-in-class therapy for PAD - but only after years of challenges in clinical trials.

The green light from the European Commission for Ixchiq marks the third regulatory approval for the world’s first vaccine for chikungunya and extends the French biotech's lead over rival Bavarian Nordic.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Scrip spoke with Amgen’s senior VP of US business operations about the impact of drug pricing and reimbursement pressures coming from government policy changes and commercial payers.

AbbVie/Genmab’s anti-CD20 bispecific is the first subcutaneous drug in the class to win approval for FL, but despite that advantage, doctors may pick the drug they know best.

The respiratory specialist is set to hit the ground running with Ohtuvayre, the first COPD inhaled product with a novel mechanism of action to be approved in over two decades.

Bristol Myers Squibb won US FDA approval in colorectal cancer for the KRAS G12C inhibitor from its $4.8bn Mirati buy, but Amgen’s first-to-market product still has a big commercial lead.

China's Dizal has won the first approval worldwide, in its home market, for a JAK1 inhibitor in relapsed/refractory peripheral T-cell lymphoma (PTCL), based on a pivotal Phase II trial. The biotech is also planning a Phase III study with the molecule for second-line PTCL.

In this week's podcast edition of Five Must-Know Things: the outlook for 2025 launches; Merck confident in new pneumococcal vaccine; multiple US setbacks for Japanese firms; Stock Watch on Moderna missteps; and Sun’s North America head talks plans and strategy.

The gene therapy is now approved for all ambulatory boys with Duchenne muscular dystrophy ages 4 and older. The revised label also includes accelerated approval for non-ambulatory patients.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

The US major's blockbuster is already well established as a treatment for Crohn’s disease but the latest thumbs-up from the US FDA means Skyrizi is the first interleukin-23 inhibitor approved for both principal types of inflammatory bowel disease.

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.

The 21-valent pneumococcal vaccine will face an entrenched competitor in Pfizer’s Prevnar 20, but Merck believes Capvaxive has a competitive advantage because it protects against serotypes specific to adults.

The FDA has approved the UK firm's checkpoint inhibitor to treat patients whose cancer is mismatch repair deficient (dMMR). The next challenge is to have a treatment for the remaining 70-80% of endometrial cancer patients with mismatch repair proficient (pMMR) disease.

Already approved for lung cancer, BMS’s ROS1/NTKK inhibitor gets US FDA accelerated approval for solid tumors that are NTRK-fusion positive.