Nieuwsfeed
- FDA Roundup: December 9, 2022
- Tissue & Tissue Products
- Cellular & Gene Therapy Products
- Allergenics
- Vaccines
- Blood & Blood Products
- Guidance and Other Information of Special Interest to MCM Stakeholders
- Valisure in the hot seat: New Form 483 over a 2021 inspection as CEO fires back
- Moving to the employer side of healthcare, Mark Cuban's Cost Plus Drugs partners with a PBM
- WIB22: Amber Salzman had few options when her son was diagnosed with a rare genetic disease. So she created a better one
- FDA reviewers head back to White Oak in 2023, with leadership looking to appease a new Congress
- Ahead of adcomm, FDA raises uncertainties on benefit-risk profile of Cytokinetics' potential heart drug
- Bags of shredded docs: Indian drugmaker Lupin handed a Form 483 by FDA inspectors
- Broken promises? FDA needs more power to remove drugs from marketplace, JAMA analysis finds
- AbbVie slapped with age discrimination lawsuit, following other pharmas
- Regulatory approval of Pfizer/BioNTech bivalent Original/Omicron booster vaccines
- Gilead, Arcellx team up on anti-BCMA CAR-T as biotech touts a 100% response rate at #ASH22
- WIB22: Leading NK cell researcher reflects on roots in Iran, the UK and Texas
- Replimune looks to rope in $225M on the back of melanoma data
- Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria
- Erasca delves further into RAS/MAPK with Novartis drug, prices $100M offering
- Phanes and BeiGene partner for advanced solid tumour therapy trial
- Horizon doses first participant in Phase I gout therapy trial
- What’s New for Biologics
- Exelixis drug fails PhIII lung cancer trial with Cabometyx and Tecentriq combo
- The Metaverse: Macroeconomic trends
- Biosimilars hit a turning point as they expand outside oncology
- WIB22: Chasing after ever-evolving science takes a drug hunter across the pond
- Scoop: Stephen Squinto’s Yale spinout is raising a Series B for genetic medicines
- Biogen vet jumps to CSO at Third Rock Treg biotech; Karuna CEO is stepping down, but this isn't goodbye
- Health Canada grants CTA authorisation for QurAlis’ ALS therapy
- Leading artificial intelligence (AI) companies in clinical trials
- Vier opgestoken middelvingers naar de Raad van State
- Autolus tips its hand, bags $220M as CAR-T showdown with Gilead looms
- Medicines: apply for a parallel import licence
- Leading cloud computing companies in clinical trials
- Leading cybersecurity companies in clinical trials
- Friday Physics: You Spin Me Right Round, Baby Right Round
- The Brazilian pharma market: Key information and what may change
- Leading Internet of Things (IoT) companies in clinical trials
- Regenxbio concludes subject dosing in Phase I/II severe MPS I trial
- Fresku legt je uit hoe het met data zit
- FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements
- DG Gel 8 ABO/Rh (2D)
- Actualización sobre el coronavirus (COVID-19): la FDA autoriza vacunas contra el COVID-19 (bivalentes) actualizadas para niños a partir de 6 meses de edad
- Recently Issued Guidance Documents
- Labeling and Promotion Guidances
- Scoop: Oncopeptides CEO ‘leaning toward’ giving in to FDA withdrawal request amid ‘pissing contest’ with regulators
- Senate Finance Chair goes after Amgen again on US taxes, asking for payment specifics
- Ready for takeoff: ARPA-H intros plan to attract project investors, commercialize products
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties