Boehringer Ingelheim has secured approval from the United States Food and Drug Administration for Jascayd (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults. The decision follows earlier FDA clearance for Jascayd in idiopathic pulmonary fibrosis and now marks the first time a preferential PDE4B inhibitor with dual immunomodulatory and antifibrotic effects has […]
Flagship Pioneering has launched a new research program with Pfizer through its portfolio company Repertoire Immune Medicines, focused on the development of T cell receptor (TCR) bispecifics for metastatic prostate cancer. This marks the eighth initiative under the broader Flagship–Pfizer strategic alliance. The program will harness Repertoire’s DECODE platform to map immune synapse interactions and […]
Soin Neuroscience and BIOTRONIK Neuro have announced a research collaboration focused on evaluating novel waveform technology and adaptive spinal cord stimulation programming aimed at enhancing chronic pain treatment outcomes. The partnership integrates proprietary signal tuning algorithms from Soin Neuroscience with the programmable Prospera SCS system developed by BIOTRONIK Neuro, reinforcing a broader industry shift toward […]
Tolmar Inc. has received expanded approval from the U.S. Food and Drug Administration for Rubraca (rucaparib), enabling its use before chemotherapy in patients with metastatic castration-resistant prostate cancer who carry BRCA mutations. The decision was based on results from the TRITON3 Phase 3 trial, which showed Rubraca to be the first and only PARP inhibitor […]
Amgen has expanded its direct-to-patient program, AmgenNow, to include Aimovig (erenumab-aooe) and Amjevita (adalimumab-atto), each now available at a flat monthly price of $299 for eligible U.S. patients. This development forms part of Amgen’s broader agreement with the Trump Administration, satisfying conditions laid out in the President’s July 31 policy letter and positioning the company […]
Hansa Biopharma AB has submitted a Biologics License Application to the U.S. Food and Drug Administration for imlifidase as a desensitization treatment in highly sensitized adult patients awaiting deceased donor kidney transplants. The submission is supported by the pivotal Phase 3 ConfIdeS trial, and the company is seeking a priority review that could lead to […]
PRISM BioLab and Talus Bio aim to drug the undruggable with AI–PPI chemistry. Find out how this platform could transform transcription factor drug discovery.
Harbour BioMed has signed a global strategic collaboration and license agreement with Bristol Myers Squibb to discover and develop next-generation multispecific antibodies. The deal could be worth over $1.1 billion across upfront payments, milestones, and royalties. It also signals growing interest in platforms capable of generating novel immunotherapies for complex diseases. The announcement is not […]
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (trastuzumab deruxtecan), in combination with pertuzumab, has received U.S. Food and Drug Administration approval as a first-line treatment for patients with unresectable or metastatic HER2-positive breast cancer, based on results from the DESTINY-Breast09 Phase III trial. The approval marks the first new frontline treatment in over a decade […]
May Health’s Anavi System wins CE Mark. Find out what this means for PCOS infertility care, clinical adoption, and regulatory pathways in Europe.