About a week after closing its $10.6 billion acquisition of Nuvalent Inc., GSK plc has reaped the first reward, announcing U.S. FDA approval of zidesamtinib in non-small-cell lung cancer (NSCLC). Branded Jideytro, the ROS1 selective inhibitor is indicated for use in adults with locally advanced or metastatic ROS1-positive disease who have received a prior ROS1 kinase inhibitor.

The decision by Agios Pharmaceuticals Inc. to end work with next-generation oral pyruvate kinase activator tebapivat in sickle cell disease (SCD) put pressure on the company’s first-generation Pyrukynd (mitapivat) and left Novo Nordisk A/S in pole position as the firm advances etavopivat toward an approval bid in the second half of this year.

Another day, another two multibillion-dollar deals with Asian companies, this time involving Dizal Pharmaceutical Co. Ltd. and its EGFR inhibitor for lung cancer, as well as Innovent Biologics Inc. and its anti-CD40L antibody for a chronic fibroinflammatory condition.

Advancell Co. Ltd. has raised an oversubscribed $315 million series D round to accelerate its push to become a fully integrated global radiopharma developer, funding late-stage clinical development alongside isotope supply and manufacturing infrastructure.

Insmed Inc. has delivered further evidence of the advantages of its once-daily pulmonary arterial hypertension (PAH) drug TPIP (treprostinil palmitil inhalation powder), with data from an open-label extension of the phase IIb trial showing patients in the treated arm maintained the benefits over 24 months.

GSK plc’s walk-away from refractory chronic cough prospect camlipixant because of dicey phase III results opened the door wider for Trevi Therapeutics Inc. with Haduvio (oral nalbuphine ER), which yielded positive phase II data in June. Shares of Trevi (NASDAQ:TRVI) closed July 17 at $19.07, up $1.71, or 9.9%. London-based GSK reported findings with camlipixant, a P2X3 receptor antagonist, from the Calm-1 and Calm-2 trials. The first met its primary endpoint, with camlipixant 50 mg twice daily showing statistically significant reductions in 24-hour cough frequency vs. placebo when measured at week 12.

Advancell Co. Ltd. has raised an oversubscribed $315 million series D round to accelerate its push to become a fully integrated global radiopharma developer, funding late-stage clinical development alongside isotope supply and manufacturing infrastructure.

For the second time in two months, Celcuity Inc. failed to generate investor excitement despite disclosing positive news, this time following the U.S. FDA approval of Revtorpyk (gedatolisib) in a subset of breast cancer patients, marking the firm’s first foray into the commercial space and introducing a new treatment option for patients. Wall Street instead focused on an unanticipated launch delay, sending shares of Celcuity (NASDAQ:CELC) down 17.6% to close July 15 at $91.51.

Island Pharmaceuticals Ltd. has secured government and ethics approvals to deploy its investigational antiviral galidesivir in patients infected during the escalating Bundibugyo Ebola outbreak in Africa, giving the small Australian biotech a rare opportunity to collect prospective human data in an active filovirus emergency.

The U.S. FDA declined to approve, for a third time, an investigational liver cancer drug regimen comprising HLB Co. Ltd.’s rivoceranib and Jiangsu Hengrui Pharmaceutical Co. Ltd.’s camrelizumab, reportedly citing issues from a drug manufacturing facility inspection.