Browsing Tag
US Food and Drug Administration
348 posts
Viatris launches $1.65bn Pacira tender, but 11-cent share-price gap limits potential upside
Viatris Inc. (NASDAQ: VTRS) has formally launched its $36.50-per-share cash tender offer for Pacira BioSciences, Inc. (NASDAQ: PCRX),…
Perrigo (PRGO) agrees to sell $380m infant formula business for $40m upfront as impairment looms
Perrigo has agreed to sell its US infant formula business to MeridianMade for up to $175 million, although only $40 million is payable at closing. The planned divestiture could improve margins and reduce future manufacturing investment, but a substantial impairment charge and weak growth in its remaining consumer health business complicate the turnaround.
Pelthos Therapeutics to acquire Castle Creek Biosciences in gene therapy merger backed by $57.5m financing
Pelthos Therapeutics has agreed to combine with Castle Creek Biosciences, adding a late-stage gene-modified cell therapy programme to its commercial dermatology portfolio. The proposed transaction includes an initial 5.2 million-share issuance, potentially substantial additional consideration and financing arrangements that could materially reshape shareholder ownership.
Cambrex begins $120m Iowa API expansion, but can new peptide capacity deliver commercial returns by 2028?
Cambrex has broken ground on its $120 million Charles City expansion, adding 160,000 litres of capacity for small molecule active pharmaceutical ingredients and synthetic peptides. The project advances a previously announced investment, supported by state incentives and employment commitments, but manufacturing qualification and commercial utilisation will determine its eventual economic contribution.
egnite and Pathway Labs launch ECG AI pilot at Stamford Health, but can early detection improve patient care?
egnite and Pathway Labs are combining FDA-cleared electrocardiogram artificial intelligence with clinical care coordination at Stamford Health, testing whether earlier identification of structural heart disease can translate into completed diagnostic evaluations and timely treatment decisions.
Enliven Therapeutics appoints Kristine Ball as $895m-backed leukemia Phase 3 trial nears
Enliven Therapeutics has expanded its board and appointed a new audit committee member as it prepares to initiate a pivotal 450-patient study of relcobatinib before the end of 2026. With FDA alignment secured on the trial design and substantial cash reserves, attention is shifting towards clinical execution, competitive differentiation and eventual commercial readiness.
Connect Biopharma cuts asthma treatment failures 66%, but endpoint misses significance
Connect Biopharma’s rademikibart reduced 28-day treatment failures by approximately 66% in a 160-patient Phase 2 acute-asthma study, but the primary endpoint missed statistical significance even as lung-function improvement reached significance and management prepares to discuss a Phase 3 programme with the FDA.
Aurobindo Pharma wins first US metered-dose inhaler approval in $301m asthma market
Aurobindo Pharma has received final USFDA approval for its first metered-dose inhaler, a beclomethasone HFA generic addressing an estimated $301 million US market and validating a respiratory-development effort that has taken several years to reach commercial approval.
Beta Bionics gets Mint FDA clearance as customers may defer up to $10m of revenue
Beta Bionics has secured FDA clearance for its Mint patch pump and moved the planned US launch forward to the first quarter of 2027, but the new product is already changing customer behaviour enough for management to cut 2026 revenue guidance by as much as $10 million.
Sleep apnoea biotech Apnimed (APMD) climbs in Nasdaq debut after upsized offering
Apnimed raised $192M in an upsized Nasdaq IPO to fund oxnimbi's launch, with the FDA's February 28, 2027 decision on the first oral OSA pill now the pivot.