Policy
FDA decisions, drug-price negotiation and the regulatory changes affecting the industry.
Policy
CSL (ASX: CSL) says it will defend Australian disclosure class action
Editorial Team22 October 2026 · 3 min
Policy
Otsuka Holdings (TSE: 4578) faces UK code findings over symposium webpage
Editorial Team22 October 2026 · 3 min
Policy
INmune Bio (INMB) sets out Ebstrocel's next UK regulatory steps
Editorial Team21 October 2026 · 3 min
Policy
Marker Therapeutics (MRKR) wins $2.6m FDA grant for pancreatic-cancer study
Editorial Team19 October 2026 · 3 min
Policy
UCB (EURONEXT BRUSSELS: UCB) Marks Next Step for Georgia Biologics Campus
Editorial Team11 October 2026 · 3 min
Policy
GSK (LSE: GSK) Commits More Than $800 Million to Pennsylvania Biologics Hub
Editorial Team9 October 2026 · 3 min
Policy
Vir Biotechnology (NASDAQ: VIR) Gains FDA Fast Track for Prostate Cancer Candidate VIR-5500
Editorial Team8 October 2026 · 3 min
Policy
Biofrontera (NASDAQ: BFRI) Seeks Broader Ameluz Label for Actinic Keratoses
Editorial Team8 October 2026 · 3 min
Policy
Agenus (NASDAQ: AGEN) Announces First BOT+BAL Authorisations in Armenia
Editorial Team8 October 2026 · 3 min
Policy
Scholar Rock (NASDAQ: SRRK) Resubmits European Apitegromab Application With Alternative Manufacturing Site
Editorial Team8 October 2026 · 3 min
Policy
CSL (ASX: CSL) Faces UK Censure Over Undisclosed Healthcare Grants
Editorial Team8 October 2026 · 3 min
Policy
Novartis (NYSE: NVS) Wins Rhapsido Expansion Into Symptomatic Dermographism
Editorial Team7 October 2026 · 3 min
Policy
Halozyme (NASDAQ: HALO) Wins European Injunction Against Merck (NYSE: MRK) on Keytruda SC
Editorial Team7 October 2026 · 3 min
Policy
60 Degrees Pharmaceuticals (NASDAQ: SXTP) Brings Babesiosis Readout Forward After Ending Enrolment
Editorial Team6 October 2026 · 3 min
Policy
Rezolute (NASDAQ: RZLT) Gets FDA Meeting Opening Despite Ersodetug Trial Miss
Editorial Team6 October 2026 · 3 min
Policy
Stoke Therapeutics (NASDAQ: STOK) Clarifies FDA Filing Plan for Zorevunersen
Editorial Team6 October 2026 · 3 min
Policy
Click Therapeutics (Private) Secures FDA Clearance for Schizophrenia Digital Treatment
Editorial Team5 October 2026 · 3 min
Policy
Equillium (NASDAQ: EQ) Secures Australian Clearance for First Human EQ504 Trial
Editorial Team5 October 2026 · 3 min
Policy
Evolus (NASDAQ: EOLS) Faces FDA Scrutiny Over Jeuveau's Beauty Marketing
Editorial Team5 October 2026 · 3 min
Policy
ILiAD Biotechnologies (Private) Publishes Paediatric Pertussis Vaccine Findings
Editorial Team3 October 2026 · 3 min
Policy
Johnson & Johnson (NYSE: JNJ) Secures Injunction Against Simponi Biosimilar Launches
Editorial Team2 October 2026 · 3 min
Policy
Ultragenyx (Nasdaq: RARE) Clears an EMA Filing Milestone for Sanfilippo Gene Therapy
Editorial Team2 October 2026 · 3 min
Policy
Bristol Myers Squibb (NYSE: BMY) Expands Camzyos Into Paediatric Care
Editorial Team2 October 2026 · 3 min
Policy
Eli Lilly (NYSE: LLY) Wins First-Line Jaypirca Approval in CLL
Editorial Team2 October 2026 · 3 min
Policy
CaseBioscience (Private) Joins Programme to Reduce Cell-Therapy Cold-Chain Dependence
Editorial Team2 October 2026 · 3 min
Policy
Cullinan Therapeutics (Nasdaq: CGEM) Begins First-Line Zipalertinib Submission
Editorial Team2 October 2026 · 3 min
Policy
US Clinical-Trial Initiative Targets Faster Evidence Generation
Editorial Team1 October 2026 · 3 min
Policy
Dunbar Pharmaceuticals (Private) Expands UK Dronabinol Supply Into Oral Sprays
Editorial Team1 October 2026 · 3 min
Policy
Atara Biotherapeutics (Nasdaq: ATRA) and Pierre Fabre (Private) Resubmit Ebvallo
Editorial Team30 September 2026 · 3 min
Policy
Fresenius (Xetra: FRE) Faces FDA Scrutiny Over Kabi's Sterile Manufacturing
Editorial Team30 September 2026 · 3 min
Policy
Beam Therapeutics (Nasdaq: BEAM) Brings Trade-Secret Claims Against Gene-Editing Rivals
Editorial Team30 September 2026 · 3 min
Policy
Pharming Seeks to Close Joenja's Paediatric Weight Gap
Editorial Team30 September 2026 · 3 min
Policy
US Essential-Medicines Plans Begin With a Capacity Inventory
Editorial Team29 September 2026 · 3 min
Policy
PhRMA Chooses Eric Cantor for Its Next Washington Chapter
Editorial Team29 September 2026 · 3 min
Policy
Ontario Makes Trial Start-Up Speed an Investment Proposition
Editorial Team29 September 2026 · 3 min
Policy
FDA Clears the First Treatment for MCT8 Deficiency
Editorial Team28 September 2026 · 3 min
Policy
BARDA Gives Scynexis a Funded Route Into Antifungal Trials
Editorial Team28 September 2026 · 3 min
Policy
Merck and Daiichi Reset Their Lung Cancer ADC Filing
Editorial Team28 September 2026 · 3 min
Policy
Lilly Loses Appeal Over Pre-Licence Obesity Drug Promotion
Editorial Team26 September 2026 · 3 min
Policy
Imfinzi Bladder Cancer Regimen Receives FDA Priority Review
Editorial Team25 September 2026 · 3 min
Policy
Nektar Wins $90 Million Verdict Against Lilly
Editorial Team25 September 2026 · 3 min
Policy
Mirum Wins FDA Approval for Rare Bone Disease Treatment
Editorial Team25 September 2026 · 3 min
Policy
Overton Hearing Puts FDA Independence at the Centre of Confirmation
Editorial Team24 September 2026 · 3 min
Policy
Empower Warning Letter Adds Manufacturing Scrutiny to GLP-1 Compounding
Editorial Team24 September 2026 · 3 min
Policy
GSK Reprimand Puts Regulatory Disclosure Under Scrutiny
Editorial Team24 September 2026 · 3 min
Policy
Grail Wins Advisory Support in a Divided Effectiveness Vote
Editorial Team24 September 2026 · 3 min
Policy
Elevar Secures FDA Approval for Targeted Bile Duct Cancer Drug
Editorial Team23 September 2026 · 3 min
Policy
AstraZeneca Extends Its Youth Health Commitment
Editorial Team23 September 2026 · 3 min
Policy
Lantheus Receives Final FDA Approval for a Lutathera Generic
Editorial Team22 September 2026 · 3 min
Policy
Ibtrozi's Label Update Adds Longer Response Follow-Up
Editorial Team22 September 2026 · 3 min
Policy
Winrevair's US Label Adds Evidence in Recently Diagnosed PAH
Editorial Team22 September 2026 · 3 min
Policy
Compass Plans a Filing Despite an FDA Request for More Evidence
Editorial Team22 September 2026 · 3 min
Policy
Grail's FDA Review Turns Attention to What the Test Can Claim
Editorial Team21 September 2026 · 3 min
Policy
Medicaid Pricing Model Draws Applications Across All 50 States
Editorial Team21 September 2026 · 3 min
Policy
Ultragenyx's Fayuvi Approval for Sanfilippo Syndrome Extends Gene Therapy Into an Overlooked Disease
Editorial Team17 September 2026 · 4 min
Policy
Roche's Lunsumio CELESTIMO Data Strengthen the Label Case for Follicular Lymphoma
Editorial Team17 September 2026 · 4 min
Policy
Bausch & Lomb's FDA Warning Letter Highlights Persistent Manufacturing Quality Risks
Editorial Team16 September 2026 · 4 min
Policy
MaaT Pharma's CHMP Negative Trend Reflects the Difficulty of the GvHD Market
Editorial Team15 September 2026 · 4 min
Policy
Montana's Experimental Treatment Law Creates a Parallel Path Outside Federal Oversight
Editorial Team15 September 2026 · 4 min
Policy
PDUFA VIII Stakeholder Meeting Sets the Agenda for the Next Fee Cycle
Editorial Team15 September 2026 · 4 min
Policy
FDA's TrialBlazer IND Pilot Promises a Faster Path for Adaptive Designs
Editorial Team15 September 2026 · 4 min
Policy
The Psychedelics Hearing Exposes a Dispute Over Who Delivers Treatment
Editorial Team15 September 2026 · 4 min
Policy
Abbott's Formula Settlement Shows Why Quality Is a Financial Issue
Editorial Team15 September 2026 · 4 min
Policy
Kenvue Deal Faces the Cost of Winning European Approval
Editorial Team15 September 2026 · 4 min
Policy
Generic Drugmakers Warn That Lower Prices Have a Limit
Editorial Team14 September 2026 · 4 min
Policy
mRNA's Recent Progress Reopens the Argument Over Research Policy
Editorial Team14 September 2026 · 4 min
Policy
The FDA's Psychedelics Hearing Puts Delivery Into the Regulatory Debate
Editorial Team14 September 2026 · 4 min
Policy
FDA Oncology's New Priorities Start With the People Doing the Reviews
Editorial Team12 September 2026 · 4 min
Policy
Biohaven's Hold Changes the Timetable Question
Editorial Team10 September 2026 · 4 min
Policy
Medicare's Next Pricing Models Need Careful Reading
Editorial Team8 September 2026 · 4 min
Policy
MFN Expands, but the Details Still Decide
Editorial Team7 September 2026 · 4 min
Policy
Overseas Trial Access Becomes a Valuation Issue
Editorial Team6 September 2026 · 4 min
Policy
Ionis' New Approval Puts Access in Focus
Editorial Team5 September 2026 · 4 min