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Feb 16, 2026
Disc Medicine received a complete response letter from the FDA for bitopertin in erythropoietic protoporphyria, with the agency requesting Phase 3 APOLLO trial results before approval. The company expects to respond by mid-2027.
Feb 16, 2026
The FDA has accepted for filing the New Drug Application for tirabrutinib under the accelerated approval pathway for relapsed or refractory primary central nervous system lymphoma, setting a PDUFA action date of December 18, 2026.
Feb 16, 2026
New data from LIBERTY studies show subcutaneous infliximab effectively restored and maintained disease control in Crohn's disease and ulcerative colitis patients after drug holiday of 16 weeks or more, with sustained efficacy through Week 102.
Feb 16, 2026
Nicox SA received positive written feedback from a pre-NDA meeting with the FDA for NCX 470, a nitric oxide-donating bimatoprost eye drop for glaucoma. The NDA submission remains on track for summer 2026.
Feb 16, 2026
CStone Pharmaceuticals received FDA IND clearance to initiate a Phase II trial of CS2009, a PD-1/VEGF/CTLA-4 trispecific antibody, in patients with advanced solid tumors across nine cancer indications.
Feb 16, 2026
Genentech's Phase III MAJESTY study showed Gazyva achieved statistically significant complete remission rates versus tacrolimus in primary membranous nephropathy, a chronic autoimmune kidney disease affecting over 96,000 people in the U.S.
Feb 16, 2026
Natco Pharma received CDSCO approval to manufacture and launch generic semaglutide injection in India next month for type 2 diabetes treatment, sending shares up over 11% on Monday.
Feb 16, 2026
Roche announced positive Phase III MAJESTY trial results showing Gazyva achieved significantly higher complete remission rates at two years versus tacrolimus in primary membranous nephropathy, with no new safety signals identified.
Feb 16, 2026
The Phase III MAJESTY study met its primary endpoint, showing significantly more people achieved complete remission at two years with Gazyva versus tacrolimus. If approved, Gazyva would be the first therapy specifically indicated for primary membranous nephropathy.
Feb 16, 2026
Roche announced that Gazyva/Gazyvaro met its primary endpoint in the Phase III MAJESTY study for primary membranous nephropathy, showing statistically significant complete remission rates versus tacrolimus. The drug could become the first approved therapy for this rare autoimmune kidney disease.
Feb 16, 2026
Shanghai Henlius Biotech received U.S. FDA approval to begin phase 1 trials of HLX15-SC, a subcutaneous biosimilar of daratumumab, for multiple myeloma treatment with significant commercial potential.
Feb 16, 2026
Health and Human Services Secretary Robert F. Kennedy Jr. announced the FDA will act on a petition to revoke GRAS status for dozens of processed sweeteners and starches, including corn syrup, unless companies prove they are safe.
Feb 16, 2026
WHOOP has partnered with Unilabs to launch its Advanced Labs programme in the UAE, offering members access to a 65-biomarker blood testing panel at Dhs733, with results integrated into the WHOOP app alongside wearable health data.
Feb 16, 2026
HHS Secretary Robert F. Kennedy Jr. announced the FDA will consider a petition to revoke GRAS status for dozens of processed sweeteners and starches, though he stopped short of promising new regulations on ultraprocessed foods.
Feb 16, 2026
CStone Pharmaceuticals received FDA IND clearance to begin a Phase II trial of CS2009, a trispecific antibody targeting PD-1, VEGF, and CTLA-4, in advanced solid tumors across nine cancer indications.
Feb 16, 2026
The Indian Health Service announced it will phase out mercury-containing dental amalgams by 2027, citing environmental and health concerns. The move affects roughly 2.8 million patients and aligns with global efforts to reduce mercury exposure.
Feb 15, 2026
With semaglutide and tirzepatide shortages resolved, the FDA is cracking down on compounded GLP-1 medications. Concerns emerge over 33 unique compounded formulations with limited safety data and nonstandard delivery methods.
Feb 15, 2026
The FDA approved KEYTRUDA and its subcutaneous QLEX formulation for platinum-resistant ovarian cancer, marking the first PD-1 inhibitor cleared for this patient population based on Phase 3 results.
Feb 15, 2026
Zydus Lifesciences Limited received final FDA approval for Ammonium Lactate Cream, 12%, a generic of Lac-Hydrin Cream. The topical prescription medication treats xerosis and ichthyosis vulgaris, with annual U.S. sales of $15 million.
Feb 15, 2026
Oncolytics Biotech announced FDA Fast Track Designation for pelareorep combined with bevacizumab and FOLFIRI for second-line treatment of KRAS-mutant metastatic colorectal cancer, driving shares up 19.7%.
