FDA approves efficacy supplement for Genentech's Gazyva
The FDA cleared supplement 43 to Gazyva's biologics license on September 25, 2026, though the agency's record does not detail the specific change.
Drugs@FDA
Latest
31 stories
Yesterday
Friday, September 25
Roche's Valium gets label update; trontinemab Alzheimer's trials continue as active, not recruiting
Thursday, September 24
New Phase Ib myeloma study registered; GSK-linked FTD trial terminated, BRCA study posted
Wednesday, September 23
Ionis and Roche report positive Phase 3 interim data for sefaxersen in IgA nephropathy
The IMAgINATION study hit its primary endpoint at 37 weeks, with the trial continuing blinded to assess kidney function through week 105.
SEC filing
Friday, September 18
Roche posts HCC trial results, registers five new studies across cancer, MS, flu, COPD
Thursday, September 10
Roche posts results for lebrikizumab COPD trial; crovalimab pediatric aHUS study nears completion
Friday, August 28
BioNTech ends Phase 2 trial of autogene cevumeran in colorectal cancer
The company halted the BNT122-01 study after a safety board found an overall survival imbalance and said further follow-up would not change the efficacy outcome.
SEC filing
Tuesday, August 25
Septerna names Rajiv Patni, M.D. as Chief Medical Officer
The GPCR-focused biotech's board appointed the physician-executive effective August 24, 2026, filling out its clinical leadership team.
SEC filing
Monday, August 24
Roche registers two Phase II trials of RO7568282 in Parkinson's and Alzheimer's disease
Thursday, August 20
Lilly registers Phase 3 depression trial; posts results for two psoriasis and oncology studies
Tuesday, August 18
Roche's glofitamab Phase 2 trial in untreated DLBCL posts results after primary completion
Monday, August 17
Maze Therapeutics adds Paula Johnson and Sophie Kornowski to board
The two appointments, effective August 13, 2026, rebalance board classes as Maze advances its kidney and metabolic disease pipeline toward late-stage development.
SEC filing
Friday, August 14
Replimune's TUDRIQEV wins FDA accelerated approval, launch set within 60 days
Replimune reports fiscal Q1 2027 results alongside the melanoma therapy's approval, a new commercial chief, and a completed $150 million financing.
SEC filing
Thursday, August 13
Olema Oncology names Jason O'Byrne as chief financial officer
The appointment, effective August 11, 2026, comes as the company approaches pivotal data from its OPERA-01 trial and prepares for a potential first commercial launch.
SEC filing
Calidi gets FDA pre-IND feedback on CLD-401, still targets Q1 2027 first dose
The company said the FDA agreed with its development strategy for the RedTail program's lead candidate, keeping the first-in-human study on track for early 2027.
SEC filing
Wednesday, August 12
Madrigal adds J&J R&D executive John C. Reed to board of directors
The company grew its board to nine seats and named Reed, who oversees Johnson & Johnson's innovative medicine research and development, to a Class II director term.
SEC filing
MaxCyte posts Q2 2026 revenue, reiterates full-year guidance
The cell-engineering company reported second quarter revenue of $7.3 million and said its Strategic Platform License pipeline continues to advance through the clinic.
SEC filing
Roche posts results for satralizumab TED trial; completes Ocrelizumab SC vs IV MS study
Tuesday, August 11
C4 Therapeutics reports Q2 2026 results, cemsidomide trials on track for 2027 data
The company said its Phase 2 MOMENTUM trial and a Phase 1b combination study of cemsidomide remain on track, with cash extending runway to the end of 2028.
SEC filing
Monday, August 10
Erasca names Charles Fuchs as President of Research & Development
The oncologist and former Genentech/Roche executive joined the biotech effective August 10, 2026, with an equity package including 1,300,000 stock options.
SEC filing
Friday, August 7
Roche results post for two terminated Morpheus umbrella trials; new Phase 1/2 studies registered
Thursday, August 6
Prothena reports Q2 2026 results, updates year-end cash guidance to $259 million
Roche published Phase 2b PADOVA data on prasinezumab in The Lancet while Prothena trimmed its 2026 cash forecast after share buybacks.
SEC filing
Lineage reports Q2 2026 results, advances COR1 corneal program and OpRegen data
Lineage highlighted three-year OpRegen data, early COR1 manufacturing progress, and a new scientific advisory board, with cash seen lasting into Q3 2028.
SEC filing
Wednesday, August 5
Recursion posts Q2 2026 results, Genentech advances first neuroscience target
The company reported a narrower net loss, lower cash operating expense guidance, and a new early discovery milestone in its neuroscience collaboration with Roche and Genentech.
SEC filing
Tuesday, August 4
IDEAYA reports Q2 2026 results, darovasertib trial hits primary endpoint
OptimUM-02 met its progression-free survival goal in metastatic uveal melanoma as IDEAYA files an NDA under FDA's real-time review program, backed by $1.24 billion in cash.
SEC filing
Friday, July 31
Roche's SatraGO-1 posts completed Phase III results; CellCept gets four-formulation label update
Tuesday, July 28
Bicara Therapeutics names two new directors as Mazumdar-Shaw exits board
The clinical-stage oncology company added Jeremy Bender and Christy Oliger to its board while founding director Kiran Mazumdar-Shaw resigned.
SEC filing
Friday, July 24
Ocrevus higher-dose Phase 3 posts results, misses primary endpoint; two partner trials update
Friday, July 17
Roche posts results for two Phase 3 lebrikizumab asthma trials; Operetta 2 update on pediatric MS
Tuesday, July 14
Ligand closes $739 million acquisition of XOMA Royalty
The deal adds seven marketed royalty products and more than 100 development-stage assets to Ligand's portfolio.
SEC filing