India caps trade margins on 137 cancer drugs at 30%, retail prices seen falling up to 70% from Nov 9
India's drug pricing regulator NPPA limited trade margins on 137 anti-cancer medicines, a move industry groups met with mixed reactions and which Karnataka said
The Economic Times · +14 outlets
Disc Medicine shares jump 60% as Phase 3 bitopertin hits primary and secondary endpoints
The late-stage win for the Roche-originated rare blood disease drug sets up an FDA resubmission after a prior rebuff, sending the stock sharply higher.
Yahoo Finance · +3 outlets
Pfizer to halt development of closely watched weight-loss drug
The move removes one of the larger challenger programs from the obesity pipeline race dominated by Lilly and Novo Nordisk.
www.polskieradio.pl · +7 outlets
FDA advisers narrowly vote to add six peptides to the drug compounding list
The advisory outcome affects which peptides compounders may legally produce, an area under scrutiny amid demand for weight-loss and wellness peptides.
The American Journal of Managed Care · +13 outlets
FDA clears Intellia's NTLA late-stage gene-editing data; ARK adds to position
Positive late-stage results for the CRISPR-based therapy lifted the shares, and Cathie Wood's ARK bought more of the name.
Stocktwits · +2 outlets
Clene submits application seeking accelerated FDA approval for its ALS drug
An accelerated approval filing could give the company a faster path to market in a disease with few treatment options.
Stock Titan · +10 outlets
FDA accepts device package for heart treatment backed by 15 trials and nearly 500 patients
Acceptance moves the heart-treatment device into the regulatory review phase.
Stock Titan · +6 outlets
Novartis discontinues mid-stage Fabhalta trial in lupus nephritis for strategic reasons
The halt trims one indication from the complement-inhibitor franchise while the company keeps its broader development plans.
Yahoo Finance · +6 outlets
Eli Lilly's Omvoh meets pediatric ulcerative colitis endpoint
The result supports expanding the bowel disease drug into pediatric patients.
Mugglehead Investment Magazine · +5 outlets
Veradermics minoxidil pill improves hair coverage in men in Phase 3
An oral formulation showed 85% of men reporting better coverage versus 35.3% on placebo, ahead of Monday presentation of the results.
BioSpace · +14 outlets
Enlivex to cut about 60% of workforce and CEO pay ahead of knee arthritis trial readout
The restructuring concentrates resources on the company's lead knee arthritis program.
Stock Titan · +2 outlets
Seraxis clears FDA for human trial of insulin-producing cell therapy
The cleared IND advances a cell therapy aimed at replacing insulin production, led by a new chief who spent 24 years at the FDA.
Stock Titan · +7 outlets
Legend Biotech clears FDA hurdle with LB2501 IND approval
The IND clearance lets the company begin clinical testing of the candidate.
Simply Wall Street
UCB wins FDA approval for ZILBRYSQ autoinjector ahead of 2027 launch
The autoinjector approval adds a self-administered format for the myasthenia gravis drug.
Mugglehead Investment Magazine · +1 outlets
Celcuity stock notches best day in about two months on first FDA approval for cancer drug
The approval follows positive breast cancer trial data and marks the company's first US regulatory clearance.
Stocktwits · +1 outlets
Teva wins Weltruza approval; Barclays raises price target to $47
The approval adds to Teva's branded portfolio, prompting an analyst target increase.
ad-hoc-news.de
Organon suspends earnings calls while Sun Pharmaceutical acquisition is pending
The pause reflects the company's transition under the pending takeover by India's Sun Pharmaceutical.
Stock Titan · +1 outlets
ImmunityBio's Anktiva gets broadest approval yet in UAE
The Gulf approval extends the reach of the IL-15 superagonist cancer therapy.
Stocktwits · +1 outlets