Oct 5, 2026

Drug Discovery Weekly — 2026-10-05

The FDA's expedited IND pilot program opened applications this week to accelerate early-stage drug development, while Novartis signed a landmark $7.8 billion licensing deal with Chinese biotech Abogen—signaling major pharma's increasing reliance on Asian innovation amid mounting patent cliff pressures. Bepirovirsen for chronic hepatitis B approaches a critical October 26 PDUFA decision.  Expedited Review Reshapes Drug Development Timeline as Mega-Pharma Doubles Down on China Deals

4 min read/15 sources

Sep 21, 2026

Drug Discovery Weekly — 2026-09-21

This week, the FDA launched a new pilot program aimed at shortening drug approval timelines, marking a significant regulatory shift. Major clinical and commercial updates included AstraZeneca's trial failure, a $1.4 billion partnership between Orbis Medicines and Novo, and the acquisition of Marea Therapeutics by Lisata Therapeutics. Meanwhile, industry reviews highlighted the ongoing integration of AI in drug discovery, with 70-90 AI-assisted candidates currently in human trials.  **FDA Launches Pilot to Shorten Drug Approval Timelines**  ![FDA building exterior](https://www.statnews.com/wp-content/uploads/2026/09/AdobeStock_310696801-1024x576.jpeg)

4 min read/15 sources

Sep 14, 2026

Drug Discovery Weekly — 2026-09-14

Scholar Rock secured a landmark FDA approval for Isembyld, the first drug targeting muscle loss in spinal muscular atrophy, marking a significant clinical win for SMA patients. Meanwhile, access issues for the recently approved pancreatic cancer drug Rasonque highlight ongoing insurance hurdles despite regulatory success.  FDA Approves First Drug Targeting SMA Muscle Loss; Access Barriers Persist for Pancreatic Cancer Drug

3 min read/15 sources

Aug 31, 2026

Drug Discovery Weekly — 2026-08-31

The FDA approved Rasonque, the first-ever targeted therapy for advanced pancreatic cancer, marking a historic milestone in oncology. Additionally, regulatory agencies authorized a new AI-based medical device for clinical neurology, and a major analysis revealed that over two-thirds of FDA approvals in 2024 were based on single-study data.

3 min read/15 sources

Aug 21, 2026

Drug Discovery Weekly — 2026-08-21

Regeneron secured FDA approval for its first-in-class therapy for fibrodysplasia ossificans progressiva (FOP), while Ultragenyx received accelerated approval for a new treatment for Gaucher disease type 1a. The week also saw a flurry of strategic M&A activity, with BioMarin and LEO Pharma acquiring rare disease assets to bolster their pipelines.

3 min read/15 sources

Jul 28, 2026

Drug Discovery Weekly — 2026-07-28

An FDA advisory panel narrowly voted to allow compounding pharmacies to produce unapproved peptides BPC-157 and KPV, marking a regulatory shift on biotech innovation. Meanwhile, biopharma dealmaking accelerated in Q2 2026 with M&A nearing $80B and licensing deals hitting a 5-year record, signaling strong market confidence. AI-designed drug candidates continue advancing through clinical trials, with Recursion's REC-4881 demonstrating the first published clinical validation of full-stack AI drug discovery.

3 min read/15 sources

Jul 14, 2026

Drug Discovery Weekly — 2026-07-14

The FDA approved Vera Therapeutics' kidney disease treatment for lupus nephritis this week, marking a significant win in autoimmune nephrology. Clinical trial momentum continues across oncology and Alzheimer's disease as biotech enters Q3. Major pharma M&A activity accelerates with Novartis, Vertex, and Ipsen leading the charge post-H1 2026.

3 min read/15 sources

Jun 30, 2026

Drug Discovery Weekly — 2026-06-30

The FDA approves oral ensitrelvir for COVID-19 postexposure prophylaxis following positive Phase 3 data, while the agency announces broader regulatory reforms—including acceptance of single-trial evidence for drug approvals—signaling a shift toward expedited pathways. Meanwhile, pharma M&A activity hits record levels, with H1 2026 exceeding $134 billion in deals as big pharma races to refill pipelines; simultaneously, AI-designed biologics enter early clinical evaluation, marking a milestone in computational drug discovery.

4 min read/15 sources

Jun 16, 2026

Drug Discovery Weekly — 2026-06-16

The FDA has officially shifted its approval standard to require only one adequate and well-controlled clinical trial for most new drugs, accelerating timelines significantly. Multiple oncology products gained clearance this week including imaging agents and diagnostics. Major pharma acquisitions totaling billions were announced, signaling continued M&A momentum and strategic repositioning across the biopharma sector.

4 min read/15 sources

Jun 9, 2026

Drug Discovery Weekly — June 9, 2026

The FDA announced a major shift toward single-trial drug approvals, significantly accelerating the path to market for new medicines. Meanwhile, biotech M&A activity surged to $106 billion—the strongest year since pre-COVID—driven by patent cliff pressures and buoyant markets. AI-designed biologics are now entering clinical evaluation, marking a watershed moment in computational drug discovery.

2 min read/15 sources

Jun 2, 2026

Drug Discovery Weekly — June 2, 2026

The FDA announced it will accept single adequate and well-controlled clinical trials as the default standard for new drug approvals, a major regulatory shift toward faster development timelines. BioMarin agreed to acquire Amicus Therapeutics for $4.8 billion, expanding its rare disease portfolio with established Fabry and Pompe franchises. Meanwhile, major pharma firms including Pfizer and Eli Lilly are striking unprecedented licensing deals with Chinese biotech companies worth billions.

4 min read/15 sources

May 19, 2026

Drug Discovery Weekly — 2026-05-19

The FDA has authorized expanded access to daraxonrasib, a RAS inhibitor for previously treated metastatic pancreatic ductal adenocarcinoma, marking a significant compassionate-use milestone for one of oncology's most intractable cancers. Bristol Myers Squibb made the week's biggest deal, inking a $15 billion biobucks partnership with China's Hengrui Pharmaceuticals to advance 13 early-stage programs. Biopharma licensing activity hit a record $82.7 billion in Q1 2026 as the industry shifts toward milestone-heavy deal structures.

7 min read/15 sources

May 12, 2026

Drug Discovery Weekly — May 12, 2026

The FDA agreed to reconsider Ebvallo, a rare-disease T-cell therapy from Pierre Fabre and Atara Biotherapeutics, after a surprise earlier rejection — with the agency now signaling a single completed trial may suffice for approval. On the deals front, two major transactions reshuffled the industry landscape: Angelini Pharma announced a $4.1 billion acquisition of Catalyst Pharmaceuticals, and Sun Pharma struck an $11.75 billion deal to acquire Organon. Lilly and Gilead continued to lead 2026's M&A surge, with deal volume substantially outpacing last year according to BioPharma Dive.

5 min read/15 sources

May 5, 2026

Drug Discovery Weekly — May 5, 2026

The FDA's landmark real-time clinical trial pilot—partnering with AstraZeneca and Amgen—marks the most significant regulatory innovation of the week, potentially compressing drug development timelines by collapsing the interval between trial phases. On the deals front, Eli Lilly and Insilico Medicine struck a $2.75 billion AI-driven licensing agreement covering a portfolio of preclinical oral therapeutics, one of the largest AI-pharma partnerships on record. The FDA also granted early expanded access to an unidentified pancreatic cancer drug, drawing broad attention to the desperate unmet need in one of oncology's most lethal diseases.

7 min read/15 sources

Apr 28, 2026

Drug Discovery Weekly — April 28, 2026

The FDA moved to fast-track three psychedelic drugs — including psilocybin and methylone — for mental health treatment this week, marking a landmark regulatory shift. AbbVie made a bold $2.1 billion acquisition of Capstan Therapeutics to gain an in vivo CAR T-cell therapy for autoimmune diseases. On the AI front, Isomorphic Labs — the Google DeepMind spinoff — announced it is readying its first AI-designed drug candidates to enter human trials.

7 min read/15 sources

Apr 14, 2026

Drug Discovery Weekly — April 14, 2026

This week delivered a string of significant FDA decisions in rare disease, with Travere's Filspari earning the FDA's first-ever approval for focal segmental glomerulosclerosis (FSGS), joining other recent wins in orphan indications. Eli Lilly's Jaypirca scored a Phase 3 CLL trial win demonstrating fixed-duration efficacy, while Regeneron made a bold $2.1B move into radiopharmaceuticals via an Australian partnership with Telix. On the deals front, Garda Therapeutics acquired Assertio and its chemotherapy drug Rolvedon for $125M, and AbbVie escalated its legal battle over the federal 340B drug discount program.

6 min read/15 sources

Apr 8, 2026

Drug Discovery Weekly — April 8, 2026

The most impactful regulatory development this week is Amgen's positive Phase 3 TEPEZZA OBI subcutaneous formulation trial in thyroid eye disease, achieving a 77% proptosis response rate. On the deals front, Gilead Sciences made its biggest splash in oncology in years with a $5 billion acquisition of German ADC biotech Tubulis, while Neurocrine Biosciences simultaneously closed its largest-ever M&A transaction by acquiring Soleno Therapeutics for $2.9 billion. Neurology trial watchers are also closely monitoring a fresh set of early 2026 readouts that could reshape CNS treatment pipelines.

7 min read/15 sources

Apr 7, 2026

Drug Discovery Weekly — April 7, 2026

Biopharma M&A momentum accelerated dramatically in March, with seven deals worth a combined $29 billion in two weeks, signaling a blockbuster year ahead; Neurocrine Biosciences announced a $2.9 billion acquisition of Soleno Therapeutics as VYKAT XR sales soar; and Q2 2026 is set up as a pivotal regulatory season, headlined by upcoming FDA decisions on Dato-DXd in TNBC and Orca-T in blood cancers.

7 min read/15 sources

Apr 6, 2026

Drug Discovery Weekly — April 6, 2026

The FDA's landmark policy shift to accept single-trial evidence for some new drug approvals is reshaping development timelines across the industry. On the deals front, Neurocrine Biosciences announced a $2.9 billion all-cash acquisition of Soleno Therapeutics, bringing a rare disease asset into its portfolio. Meanwhile, Capricor Therapeutics reported positive Phase 3 topline results for deramiocel in Duchenne Muscular Dystrophy, meeting both its primary and key secondary cardiac endpoints.

7 min read/15 sources

Apr 5, 2026

Drug Discovery Weekly — April 5, 2026

BioMarin's $4.8 billion all-cash acquisition of Amicus Therapeutics stands as this week's landmark deal, dramatically expanding the rare disease portfolio of both companies. On the regulatory front, FDA novel drug approvals continue to accumulate in Q2 2026, with multiple PDUFA decisions on the horizon. And in clinical trial news, Capricor Therapeutics reported positive topline results from its pivotal Phase 3 HOPE-3 study of deramiocel in Duchenne Muscular Dystrophy, meeting both its primary and key secondary endpoints.

7 min read/15 sources

Drug Discovery Weekly

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