FDA approves supplement for Novartis's Kisqali Femara Co-Pack
A priority efficacy supplement for the combination tablet package was approved, with the label update dated July 10, 2026.
Drugs@FDA
Latest
Wednesday, July 1
FDA clears new efficacy supplement for Novartis's Kisqali
The agency approved supplement 27 to Kisqali's application under priority review, with a label update dated July 10, 2026.
Drugs@FDA
Quantum Cyber subsidiary signs deals for Bridgeport manufacturing site
Quantum Drones Corporation agreed to buy a Connecticut facility and its equipment for $3.2 million, part of Quantum Cyber's shift toward domestic defense manufacturing.
SEC filing
Cumberland closes $100 million asset sale to Apotex, keeps rare disease pipeline
Cumberland Pharmaceuticals completed the sale of six branded products to an Apotex affiliate on July 1, 2026, retaining its ifetroban programs.
SEC filing
PMGC subsidiary reports positive Phase III results from AI drug discovery work with Yuva Biosciences
NorthStrive Biosciences said four compounds selected by Yuva's MitoNova AI platform raised ANT1 protein levels in muscle cell testing, with next steps still under evaluation.
SEC filing
Amgen recalls Sensipar and Corlanor lots; BKEMV biosimilar gets label update
Biogen flags Q2 and Q3 2026 charges tied to licensing and milestone deals
Biogen disclosed preliminary estimates of in-process R&D and milestone expense for the second and third quarters of 2026, tied to collaboration payments and pending transactions.
SEC filing
INmune Bio strikes warrant inducement deal, extends maturity on remaining warrants
The company will collect about $906,000 from holders exercising half of its April 2024 warrants at a reduced price, while pushing the deadline on the rest to December 2027.
SEC filing
Neurogene prices upsized stock offering, raises $134.8 million net
The company sold shares and pre-funded warrants and expects proceeds to fund operations into early 2029.
SEC filing
OneMedNet signs $25 million standby equity purchase deal with Yorkville
The agreement, dated July 1, 2026, lets OneMedNet sell shares to Yorkville over 36 months, subject to volume limits and an ownership cap.
SEC filing
Viatris amends and restates yen term loan facility with Mizuho as agent
Viatris entered a new agreement for a ¥40 billion senior unsecured term loan, with proceeds set to repay its 2021 facility of the same size.
SEC filing
eXoZymes closes $639,990 follow-on offering with MDB Capital
The Nasdaq-listed company sold 35,555 units at $18.00 each on June 30, 2026, tied to warrant terms from its earlier June 5 underwriting.
SEC filing
Jade Biosciences licenses undisclosed target antibody program from Paragon
The June 29, 2026 deal, designated JADE301, could require up to $22.0 million in development and regulatory milestone payments plus additional sublicensing fees.
SEC filing
Tuesday, June 30
InflaRx weighs broader EU strategy for vasculitis drugs after Tavneos setback
The company will approach European regulators about both vilobelimab and izicopan for ANCA-associated vasculitis after a CHMP panel recommended pulling Tavneos from the EU market.
SEC filing
Moleculin reports interim MIRACLE data showing higher remission with Annamycin
In 45 evaluable patients, both Annamycin dose arms beat the control arm on complete remission, though the trial's data monitoring committee found no statistical significance at this early stage.
SEC filing
Addex shareholders back all board proposals at 2026 annual meeting
Voting covered 29.35% of outstanding capital, with re-elections to the board and approval of capital structure amendments.
SEC filing
Akebia and USRC halt VOICE trial early after Vafseo beats ESA on safety
An interim analysis showed vadadustat, dosed three times weekly, cut hospitalizations versus an ESA, meeting prespecified stopping rules.
SEC filing
Vistagen's fasedienol misses primary endpoint in PALISADE-4 trial
The Phase 3 trial failed on its main and secondary measures, but a post-hoc subgroup analysis showed a nominally significant effect in patients with very severe social anxiety disorder.
SEC filing
Pacira to divest iovera° cryoneurolysis business to Zimmer Biomet
The deal is worth up to $140 million, with $70 million upfront and $70 million in potential revenue-based milestones through 2031.
SEC filing
AC Immune reports 12-month interim data from ABATE trial of ACI-24
The Phase 1b/2 trial showed antibody dose response with no ARIA-E across the first three Alzheimer's cohorts, while a fourth cohort testing an added adjuvant is underway.
SEC filing
XTL Biopharmaceuticals completes acquisition of Psyga Bio, pivots to psychedelic medicine
XTL took an 83.40% stake in Psyga Bio through an ADS issuance and raised $1.5 million in a private placement to fund the newly combined pipeline.
SEC filing
BeiGene's LBL-007/tislelizumab colorectal cancer trial posts results
Amckaus registers Phase 2 trial of Aom0304 for hypertrophic cardiomyopathy
eXoZymes prices offering of stock-and-warrant units for $18 each
The Nasdaq-listed company set terms for a placement of 35,555 units, with warrants exercisable starting June 5, 2027, and expects roughly $565,206 in net proceeds.
SEC filing
Celularity secures $1 million loan from trust tied to major shareholder Philip Barach
The 8-K discloses a related-party loan agreement and the resignation of a board member, both dated late June 2026.
SEC filing
Kymera registers long-term extension study for KT-621 in asthma patients
Aptevo gets $1.5 million grant to advance solid tumor immunotherapy APVO451
The Andy Hill CARE Fund will reimburse Aptevo up to $1,499,951 for IND-enabling work on its nectin-4-targeted trispecific candidate through June 2028.
SEC filing
Nuvectis Pharma prices $100 million public stock offering at $20 per share
The clinical stage biopharma priced 5,000,000 shares with underwriters holding an option for 750,000 more, expecting to close July 1, 2026.
SEC filing (3)
Jupiter Neurosciences adds health economist Tomas Philipson to board
The Nasdaq-listed company appointed Philipson to its board and audit and compensation committees effective June 26, 2026, granting him stock options in place of cash pay.
SEC filing
ALX Oncology names Scott Garland chairman, hires Michael Listgarten as general counsel
The moves follow Corey Goodman's resignation as chairman for personal reasons, effective June 29, 2026.
SEC filing
Palvella Therapeutics adds Matthew Pauls to board of directors
The Savara CEO joins Palvella's board as an eighth director, bringing prior experience from Strongbridge Biopharma and Soleno Therapeutics.
SEC filing
Hutchmed sets July 30, 2026 date for first-half financial results
The company will report interim 2026 results and hold webcasts in English and Putonghua the same week.
SEC filing
Zevra Therapeutics posts results for Phase 2 SDX trial in idiopathic hypersomnia
Rocket Pharmaceuticals names Joseph Manhede as principal accounting officer
The change follows John Militello's resignation as VP of Finance, effective July 7, 2026, with Manhede stepping in the next day.
SEC filing
Gilead's Phase 2 obeldesivir RSV trial terminated by sponsor; results posted
Stoke Therapeutics completes enrollment of 162-patient Phase 3 EMPEROR trial for zorevunersen
Rolling U.S. NDA submission is planned for early 2027, with a Phase 3 data readout expected in the third quarter of that year to finish the filing.
SEC filing
bioAffinity reports CyPath Lung sales growth and Philips veteran screening collaboration
The company's second-quarter 2026 newsletter details rising CyPath Lung test orders, a new Philips partnership, and early skin cancer research findings.
SEC filing
UT Southwestern registers RIPCORD trial testing PSMA PET-guided radiotherapy in prostate cancer
Outlook Therapeutics posts NORSE EIGHT phase 3 results for ONS-5010 in wet AMD
Getz Pharma registers community NCD screening study in Faisalabad, Pakistan
Jaguar Health files two Form D notices for equity offerings totaling $42.8 million
The San Francisco pharmaceutical company reported one offering fully sold at $40.8 million and a second at $2 million, both dated for first sale on June 9, 2026.
SEC filing (2)
Exicure expands board, adds two directors, forms compensation committee
Ham Jung Kyu resigned from Exicure's board effective June 30, 2026, as the company grew its board to six members and appointed Go Jin Young and Han Eui Seok as directors.
SEC filing
Disc Medicine files 8-K on Hercules loan amendment signed June 25, 2026
The filing confirms tranche restructuring and a delayed minimum cash covenant test date of July 1, 2028, with full terms to follow in the next 10-Q.
SEC filing
Merck's MK-1403 bioavailability trial listed as completed in registry update
Xeris CEO John Shannon named Board chair, adds new director Kreher
Xeris Biopharma named CEO John Shannon as Board Chair and appointed physician-scientist Nerissa Kreher as a new director, both effective July 1, 2026.
SEC filing
Mesoblast gets BLA filing number for rexlemestrocel-L in LVAD patients
The company asked FDA for a modular review of the cell therapy for preventing serious GI bleeding tied to right heart dysfunction in end-stage heart failure patients on LVAD support.
SEC filing
Annexon posts results for ANX005 Phase 2 wAIHA study, completed with 7 participants
Imunon names Josh Blacher interim CFO as Jeffrey Church retires
The company disclosed the CFO transition in an 8-K reporting an event date of June 29, 2026, with Blacher installed through a master services agreement with Danforth Health.
SEC filing