Browsing Tag
FDA
293 posts
Biotech breakthrough in PTSD? Silo Pharma and Allucent move toward FDA IND filing for SPC-15 therapy
Silo Pharma partners with Allucent to advance its planned FDA IND for intranasal PTSD therapeutic SPC-15. Find out how this collaboration could shape future mental health treatment.
Why the FDA’s warning on Elevidys matters for Duchenne muscular dystrophy treatment
Sarepta’s Elevidys gene therapy now carries an FDA boxed warning. Find out what it means for Duchenne patients, investors, and gene therapy safety.
BrainStorm Cell Therapeutics (OTCQB: BCLI) narrows Q3 2025 loss as ALS trial preps advance and cash runway tightens
BrainStorm Cell Therapeutics narrows Q3 loss and prepares for pivotal ALS trial. Find out why 2026 could be a make-or-break year for the biotech company.
Clairity raises $43m to scale first FDA-authorized AI platform for breast cancer risk prediction
Find out how Clairity’s FDA-authorized AI platform and $43M Series B funding aim to transform breast cancer risk prediction and preventive care.
Tandem Diabetes Care wins FDA clearance to bring its Tandem Mobi insulin pump app to Android users
Find out how Tandem Diabetes Care’s FDA clearance for its Android app expands insulin pump access and reshapes the diabetes tech market.
Infant formula recall: Why ByHeart pulled two batches despite no contamination evidence
ByHeart recalls two batches of infant formula amid FDA’s botulism probe. Find out why the company acted despite no contamination reports.
Darzalex Faspro moves closer to FDA approval as first therapy for high-risk smoldering multiple myeloma
Find out how Darzalex Faspro could become the first FDA-approved therapy for high-risk smoldering multiple myeloma, reshaping early myeloma care.
Rhythm Pharmaceuticals’ IMCIVREE hits regulatory speed bump as FDA extends decision timeline into 2026
Find out how Rhythm Pharmaceuticals’ IMCIVREE FDA review delay could shape the rare obesity treatment market in 2026.
Palatin Technologies to raise $15.8m in public offering; NYSE relisting expected Nov 12
Palatin Technologies regains NYSE American compliance and secures $15.8M for its oral MC4R obesity drug. Find out how the relisting and IND impact its biotech trajectory.
Relmada gains FDA support for dual Phase 3 study paths of NDV-01 in non-muscle invasive bladder cancer
Find out how Relmada secured FDA alignment on dual Phase 3 paths for NDV-01 in NMIBC, opening two routes toward approval and a potential new bladder-sparing therapy.