| Biogen’s AdComm Meeting Will Test FDA’s “Substantial Evidence” Flexibility | Sue Sutter | 10/08/20 | Boston |
| Neurology at Forefront of FDA’s Complex Innovative Trial Design Pilot | Bridget Silverman | 04/16/20 | National |
| FDA Rejects Sarepta’s Second Duchenne Drug, Citing Safety Concerns | Ben Fidler | 08/19/19 | Boston |
| Four New Drugs Are Around the Corner. Here’s What You Need to Know. | Ben Fidler | 08/15/19 | National |
| Duchenne Advocates Start Casimir, Aiming to Capture Missing Data | Ben Fidler | 07/26/19 | Boston |
| Amicus Finally Wins FDA Nod, Will Price Fabry Drug Below Rivals | Ben Fidler | 08/10/18 | New York |
| FDA’s Rachel Sherman on Right to Try, Succession Trouble & More | Ben Fidler | 02/13/18 | New York |
| FDA Panel Pans PTC’s Audacious Plan to Force Vote on Duchenne Drug | Ben Fidler | 09/28/17 | New York |
| Bio Roundup: RNAi’s Big Day, CAR-T For Kids, Drugs From Fungi & More | Ben Fidler | 09/22/17 | National |
| Immunotherapy Safety Worries Halt Celgene Myeloma Study, Slow 5 Others | Alex Lash | 09/07/17 | New York |
| Woodcock: New Approvals Show FDA Is Adapting to Precision Medicine | Frank Vinluan | 05/30/17 | National |
| After Sarepta’s Surprising FDA Nod, CEO Kaye Plans to Resign | Ben Fidler | 04/28/17 | Boston |
| Often Advocates Of Faster FDA, Patient Groups Wary Of Trump Deregulation | Alex Lash | 02/10/17 | National |
| Ex-FDA Commish Califf Gives Props to Patient Groups—With Caveats | Alex Lash | 01/23/17 | National |
| Notes From The JPM ’17 Vortex: Trump, Rainstorms & The Price You Pay | Alex Lash | 01/13/17 | National |
| Senate Approves 21st Century Cures Act, Sending Bill to Obama | Frank Vinluan | 12/07/16 | National |
| Defying Patient Pressure, Anthem Says No to Sarepta’s Duchenne Drug | Ben Fidler | 10/07/16 | Boston |
| Bio Execs Talk Patient Advocacy, Duchenne Approval at BioForward Panel | Jeff Buchanan | 09/28/16 | Wisconsin |
| Bio Roundup: Mylan Grilled, Duchenne Kids Thrilled, Zuck-Chan & More | Alex Lash | 09/23/16 | National |
| Sarepta Preps For Sales As Insurers Unlikely To Deny Duchenne Drug | Ben Fidler | 09/22/16 | Boston |
| Sarepta Prices $300K Duchenne Drug As FDA Rift Emerges Over Approval | Ben Fidler | 09/19/16 | Boston |
| After New Data, FDA Bucks Advisory Panel, Approves Sarepta’s Duchenne Drug | Ben Fidler | 09/19/16 | Boston |
| Duchenne Lessons: Advocates For Rare Spinal Disease Have Eyes on FDA | Ben Fidler | 08/26/16 | National |
| Sarepta Saga Drags On as FDA Delays Decision on Duchenne Drug | Ben Fidler | 05/25/16 | Boston |
| Near-Term FDA Nod Unlikely For Duchenne Drug After Negative Vote | Ben Fidler | 04/25/16 | Boston |
| If You’ve Got a Real Breakthrough, the FDA Wants To Talk | Luke Timmerman | 01/14/13 | National |
| Vivus Wins FDA Approval for Obesity Drug, After Long, Messy Day | Luke Timmerman | 07/17/12 | San Francisco |
| The Cancer Drug Dark Ages Are Coming to an End | Luke Timmerman | 10/31/11 | National |
| Alkermes Sees Chance to Reinvent Vivitrol For Fighting Drug Addiction, Not Just Alcoholism | Luke Timmerman | 02/18/11 | Boston |
| Momenta Pharma Competitor Lodges Ethics Complaint Against FDA Boss, WSJ Reports | Ryan McBride | 08/12/09 | Boston |
