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Apr 28, 2026
AbbVie filed an sBLA for SKYRIZI as a subcutaneous induction therapy for Crohn's disease, supported by Phase 3 AFFIRM data. SKYRIZI and Rinvoq combined for $25.9B in 2025 revenue, exceeding 2027 guidance. The FDA also approved Venclexta plus acalabrutinib in CLL.
Apr 27, 2026
GENFIT will receive a $20 million milestone from Ipsen after Iqirvo posted $208 million in 2025 net sales in primary biliary cholangitis. The sales also triggered a €30 million instalment under GENFIT’s royalty-financing deal.
Apr 27, 2026
Kyowa Kirin and Kura Oncology started a Japanese Phase II registrational study of ziftomenib in adults with relapsed or refractory NPM1-mutated AML. Kyowa Kirin plans to seek regulatory approval in Japan after the trial.
Apr 27, 2026
Veradermics will host an April 27, 2026 investor call to review topline results from Part A of its Phase 2/3 '302' trial of VDPHL01 in males with pattern hair loss. VDPHL01 is an investigational extended-release oral minoxidil tablet in Phase 3 development.
Apr 27, 2026
The FDA approved AstraZeneca’s Saphnelo Pen for once-weekly self-administration in adults with systemic lupus erythematosus. Approval was based on Phase III TULIP-SC results showing reduced disease activity versus placebo.
Apr 27, 2026
The FDA approved Keytruda and Keytruda Qlex with paclitaxel, with or without bevacizumab, for PD-L1-positive platinum-resistant ovarian-related cancers. The Phase III KEYNOTE-B96 trial showed improved progression-free and overall survival versus placebo.
Apr 27, 2026
The Lancet refused a U.S. Senate request for evidence on COVID-19 origins. Purdue Pharma's sentencing was delayed, while insurers moved to reduce prior-authorization paperwork.
Apr 26, 2026
The pharmaceutical manufacturing market is projected to reach $1.24 trillion by 2032, while the continuous manufacturing market is expected to reach $4.2 billion by 2040. Growth is tied to biologic drug demand, digital platforms, automation, and regulatory support.
Apr 26, 2026
Morphic Medical’s Reset obesity treatment device received NUB status in Germany, allowing hospitals to seek supplementary reimbursement. The company said U.S. FDA study enrollment is continuing after protocol changes to accelerate recruitment.
Apr 26, 2026
More than 30 approved cell and gene therapies carry prices from nearly $1 million to over $4 million, creating fiscal pressure for Medicaid. A federal access model launched in 2024 aims to centralize outcomes-based contracting.
Apr 26, 2026
Isomorphic Labs said one AI-designed drug, ISM8969, has FDA clearance for human clinical trials. The company’s initial pipeline focuses on oncology candidates.
Apr 26, 2026
Merck received FDA approval in early February 2026 for KEYTRUDA and KEYTRUDA QLEX in PD-L1-positive platinum-resistant ovarian cancer. The decision marks the first approval of a PD-1 inhibitor regimen for this setting.
Apr 26, 2026
Medtronic reported interim Affera Sphere-9 data showing 65.5% of VT patients were free from recurrence at six months. The FDA granted Breakthrough Device designation for Sphere-9 and approved a U.S. pivotal IDE.
Apr 25, 2026
BridgeBio shares rose 2.10% to $69.41 after Phase 3 FORTIFY interim data for oral BBP-418 in LGMD2I/R9 showed broad efficacy and placebo-matched safety. The company plans a U.S. FDA filing in H1 2026.
Apr 25, 2026
US health policy activity this week included HHS FY 2027 budget hearings, a House review of Medicare fraud and bipartisan discussion of PBM reform. President Trump also issued an executive order on mental illness treatments, and CMS and FDA announced the RAPID pathway.
Apr 25, 2026
ImmunityBio has commercially launched ANKTIVA in Saudi Arabia for approved bladder and metastatic non-small cell lung cancer indications. The launch follows accelerated approval in lung cancer and extends the drug’s commercial rollout in MENA.
Apr 25, 2026
BioNTech enters May with first-quarter earnings due May 5 and a May 15 shareholder vote on a capital increase. The company is pushing its oncology pipeline as COVID-19 vaccine sales decline.
Apr 25, 2026
Moderna shares rose after the company reported quarterly results that beat earnings and revenue estimates. The stock move came as investors also weighed an FDA refusal-to-file for its mRNA flu vaccine and ongoing funding concerns.
Apr 24, 2026
Kymera said the FDA granted Fast Track designation to KT-621 for moderate to severe eosinophilic asthma, while Gilead licensed KT-200 and triggered a $45 million milestone payment.
Apr 24, 2026
Novartis received a positive CHMP opinion for Itvisma in spinal muscular atrophy patients aged 2 years and older. A European Commission decision is expected within about two months.
